<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981368</url>
  </required_header>
  <id_info>
    <org_study_id>PyL 2301</org_study_id>
    <nct_id>NCT02981368</nct_id>
  </id_info>
  <brief_title>Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer</brief_title>
  <acronym>OSPREY</acronym>
  <official_title>A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Progenics Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Progenics Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in&#xD;
      patients with at least high risk prostate cancer who are planned for radical prostatectomy&#xD;
      with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease&#xD;
      willing to undergo biopsy (Cohort B).&#xD;
&#xD;
      Cohort B is complete and no longer recruiting subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)</measure>
    <time_frame>From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).</time_frame>
    <description>Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)</measure>
    <time_frame>From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).</time_frame>
    <description>Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)</measure>
    <time_frame>Changes in ECG pre-drug dosing and within 1-2 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)</measure>
    <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</measure>
    <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</measure>
    <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)</measure>
    <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</measure>
    <time_frame>Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.</time_frame>
    <description>Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging</measure>
    <time_frame>Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken</time_frame>
    <description>The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</measure>
    <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
    <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</measure>
    <time_frame>Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.</time_frame>
    <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants</measure>
    <time_frame>Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants</measure>
    <time_frame>Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">385</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-DCFPyL Injection</intervention_name>
    <description>A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL</description>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
    <other_name>PyL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/CT imaging</intervention_name>
    <description>PET/CT imaging will be acquired 1-2 hours post-PyL injection</description>
    <arm_group_label>18F-DCFPyL Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed adenocarcinoma of the prostate.&#xD;
&#xD;
          2. Subjects provide signed informed consent and confirm that they are able and willing to&#xD;
             comply with all protocol requirements.&#xD;
&#xD;
        Cohort A Only:&#xD;
&#xD;
          -  At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical&#xD;
             stage ≥T3a or PSA &gt;20 ng/mL or Gleason score ≥8).&#xD;
&#xD;
          -  Scheduled or planned radical prostatectomy with PLND.&#xD;
&#xD;
        Cohort B Only: [Enrollment is complete; No longer recruiting subjects]&#xD;
&#xD;
          -  Radiologic evidence of local recurrence or new or progressive metastatic disease&#xD;
             demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan&#xD;
             (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.&#xD;
&#xD;
          -  If prior treatment with radiation or ablative therapy, evidence of recurrence outside&#xD;
             the confines of prior treated site(s) is needed.&#xD;
&#xD;
          -  Scheduled or planned percutaneous biopsy of at least one amenable lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects administered any high energy (&gt;300 KeV) gamma-emitting radioisotope within&#xD;
             five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any&#xD;
             high density oral contrast medium (oral water contrast is acceptable) within 5 days,&#xD;
             prior to study drug injection.&#xD;
&#xD;
          2. Subjects with any medical condition or other circumstance that, in the opinion of the&#xD;
             investigator, compromise obtaining reliable data, achieving study objectives, or&#xD;
             completion.&#xD;
&#xD;
        Cohort A Only:&#xD;
&#xD;
          -  Patients with prior androgen deprivation therapy or any investigational neoadjuvant&#xD;
             agent or intervention&#xD;
&#xD;
        Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]&#xD;
&#xD;
          -  Prior radiation or ablative therapy to intended site of biopsy, if within the prostate&#xD;
             bed&#xD;
&#xD;
          -  Initiation of new therapy for recurrent and/or progressive metastatic disease since&#xD;
             radiographic documentation of recurrence/progression.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Morris, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth J Pienta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California at San Francisco (UCSF) - Mt. Zion Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University Department of Radiology and Biomedical Imaging</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Mallinckrodt Institute of Radilogy</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Quebec (CHUQ)</name>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>May 16, 2021</results_first_submitted>
  <results_first_submitted_qc>August 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2021</results_first_posted>
  <disposition_first_submitted>September 12, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>September 12, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 20, 2019</disposition_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diagnostic</keyword>
  <keyword>Imaging</keyword>
  <keyword>2301</keyword>
  <keyword>PET/CT</keyword>
  <keyword>PyL</keyword>
  <keyword>PSMA</keyword>
  <keyword>radical prostatectomy</keyword>
  <keyword>metastatic prostate cancer</keyword>
  <keyword>recurrent prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02981368/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02981368/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>High Risk Prostate Cancer (Cohort A)</title>
          <description>Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
        <group group_id="P2">
          <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
          <description>Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="248"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population; total number of patients who received 18F-DCFPyL injection.</population>
      <group_list>
        <group group_id="B1">
          <title>High Risk Prostate Cancer (Cohort A)</title>
          <description>Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
        <group group_id="B2">
          <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
          <description>Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="268"/>
            <count group_id="B2" value="117"/>
            <count group_id="B3" value="385"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="46" upper_limit="84"/>
                    <measurement group_id="B2" value="68" lower_limit="45" upper_limit="86"/>
                    <measurement group_id="B3" value="66" lower_limit="45" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="268"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="233"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.9" lower_limit="94.52" upper_limit="99.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="96.00" upper_limit="99.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.3" lower_limit="93.64" upper_limit="98.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" lower_limit="29.65" upper_limit="54.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="19.17" upper_limit="42.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" lower_limit="28.11" upper_limit="52.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)</title>
        <description>Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
        <time_frame>From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - Follow-up Value: Low</title>
            <description>Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Follow-up Value: Low</title>
            <description>Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.</description>
          </group>
          <group group_id="O3">
            <title>Cohort A - Follow-up Value: Normal</title>
            <description>Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B - Follow-up Value Normal</title>
            <description>Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.</description>
          </group>
          <group group_id="O5">
            <title>Cohort A - Follow-up Value: High</title>
            <description>Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O6">
            <title>Cohort B - Follow-up Value: High</title>
            <description>Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.</description>
          </group>
          <group group_id="O7">
            <title>Cohort A - Follow-up Value: Missing</title>
            <description>Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O8">
            <title>Cohort B - Follow-up Value: Missing</title>
            <description>Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.</description>
          </group>
        </group_list>
        <measure>
          <title>Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)</title>
          <description>Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="117"/>
                <count group_id="O3" value="268"/>
                <count group_id="O4" value="117"/>
                <count group_id="O5" value="268"/>
                <count group_id="O6" value="117"/>
                <count group_id="O7" value="268"/>
                <count group_id="O8" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="197"/>
                    <count group_id="O4" value="53"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="179"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="47"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="218"/>
                    <count group_id="O4" value="50"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="210"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="43"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="237"/>
                    <count group_id="O4" value="72"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="230"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="13"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="70"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="205"/>
                    <count group_id="O4" value="42"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="194"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="39"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="220"/>
                    <count group_id="O4" value="75"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="14"/>
                    <count group_id="O8" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="208"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="71"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)</title>
        <description>Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
        <time_frame>From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - Follow-up Value: Low</title>
            <description>Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Follow-up Value: Low</title>
            <description>Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.</description>
          </group>
          <group group_id="O3">
            <title>Cohort A - Follow-up Value: Normal</title>
            <description>Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B - Follow-up Value: Normal</title>
            <description>Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.</description>
          </group>
          <group group_id="O5">
            <title>Cohort A - Follow-up Value: High</title>
            <description>Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O6">
            <title>Cohort B - Follow-up Value: High</title>
            <description>Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.</description>
          </group>
          <group group_id="O7">
            <title>Cohort A - Follow-up Value: Missing</title>
            <description>Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.</description>
          </group>
          <group group_id="O8">
            <title>Cohort B - Follow-up Value: Missing</title>
            <description>Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.</description>
          </group>
        </group_list>
        <measure>
          <title>Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)</title>
          <description>Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.</description>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="117"/>
                <count group_id="O3" value="268"/>
                <count group_id="O4" value="117"/>
                <count group_id="O5" value="268"/>
                <count group_id="O6" value="117"/>
                <count group_id="O7" value="268"/>
                <count group_id="O8" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="218"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="13"/>
                    <count group_id="O7" value="39"/>
                    <count group_id="O8" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="210"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="38"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="61"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="207"/>
                    <count group_id="O4" value="67"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="40"/>
                    <count group_id="O8" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="197"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="35"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="67"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="199"/>
                    <count group_id="O4" value="61"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="45"/>
                    <count group_id="O8" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="193"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="43"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="60"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="200"/>
                    <count group_id="O4" value="70"/>
                    <count group_id="O5" value="28"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="39"/>
                    <count group_id="O8" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="194"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="33"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="69"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="223"/>
                    <count group_id="O4" value="83"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="18"/>
                    <count group_id="O8" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="219"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="18"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="81"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="231"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="223"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="15"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="66"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="178"/>
                    <count group_id="O4" value="39"/>
                    <count group_id="O5" value="73"/>
                    <count group_id="O6" value="43"/>
                    <count group_id="O7" value="17"/>
                    <count group_id="O8" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="155"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="25"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="14"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="53"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="29"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="237"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="7"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="19"/>
                    <count group_id="O8" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="226"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="18"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="75"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="235"/>
                    <count group_id="O4" value="58"/>
                    <count group_id="O5" value="15"/>
                    <count group_id="O6" value="24"/>
                    <count group_id="O7" value="15"/>
                    <count group_id="O8" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Cohort A - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="222"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="12"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="54"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="16"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort A - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cohort B - Baseline Value: Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)</title>
        <time_frame>Changes in ECG pre-drug dosing and within 1-2 hours post-dosing</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A) - Baseline ECG</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.</description>
          </group>
          <group group_id="O2">
            <title>High Risk Prostate Cancer (Cohort A) - Post-dosing ECG</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.</description>
          </group>
          <group group_id="O3">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
          <group group_id="O4">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)</title>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="260"/>
                <count group_id="O2" value="264"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal ECG Evaluation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="155"/>
                    <measurement group_id="O3" value="55"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal ECG Evaluation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="109"/>
                    <measurement group_id="O3" value="59"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
        <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
          <group group_id="O2">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure: Baseline (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.7" spread="15.99"/>
                    <measurement group_id="O2" value="133.6" spread="19.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Post-dosing (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.7" spread="16.57"/>
                    <measurement group_id="O2" value="132.1" spread="19.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="12.30"/>
                    <measurement group_id="O2" value="-1.3" spread="11.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Baseline (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3" spread="8.62"/>
                    <measurement group_id="O2" value="77.2" spread="10.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Post-dosing (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.5" spread="9.12"/>
                    <measurement group_id="O2" value="76.4" spread="9.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="7.04"/>
                    <measurement group_id="O2" value="-0.7" spread="8.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
        <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
          <group group_id="O2">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="268"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart Rate: Baseline (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7" spread="12.03"/>
                    <measurement group_id="O2" value="71.3" spread="12.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Rate: Post-dosing (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4" spread="10.98"/>
                    <measurement group_id="O2" value="67.0" spread="11.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Rate: Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="6.88"/>
                    <measurement group_id="O2" value="-4.6" spread="6.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
        <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
          <group group_id="O2">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="265"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Respiration Rate: Baseline (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="3.33"/>
                    <measurement group_id="O2" value="17.3" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiration Rate: Post-dosing (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="260"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="3.32"/>
                    <measurement group_id="O2" value="17.3" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiration Rate: Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="260"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="2.03"/>
                    <measurement group_id="O2" value="0.0" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
        <time_frame>Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.</time_frame>
        <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
          <group group_id="O2">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)</title>
          <population>The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).</population>
          <units>degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="266"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Temperature: Baseline (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.58" spread="0.433"/>
                    <measurement group_id="O2" value="36.56" spread="0.338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: Post-dosing (Actual)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="263"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.50" spread="0.479"/>
                    <measurement group_id="O2" value="36.59" spread="0.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="261"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.496"/>
                    <measurement group_id="O2" value="0.03" spread="0.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
        <description>Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).</description>
        <time_frame>Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.</time_frame>
        <population>Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.</population>
        <group_list>
          <group group_id="O1">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
          <description>Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).</description>
          <population>Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="91.60" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.8" lower_limit="87.81" upper_limit="99.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="83.98" upper_limit="97.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging</title>
        <description>The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.</description>
        <time_frame>Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken</time_frame>
        <population>The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - Conventional Imaging</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.</description>
          </group>
          <group group_id="O2">
            <title>Cohort A - 18F-DCFPyL PET/CT: Reader 1</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
          <group group_id="O3">
            <title>Cohort A - 18F-DCFPyL PET/CT: Reader 2</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
          <group group_id="O4">
            <title>Cohort A - 18F-DCFPyL PET/CT: Reader 3</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
          <group group_id="O5">
            <title>Cohort B - Conventional Imaging</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.</description>
          </group>
          <group group_id="O6">
            <title>Cohort B - 18F-DCFPyL PET/CT: Reader 1</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
          <group group_id="O7">
            <title>Cohort B - 18F-DCFPyL PET/CT: Reader 2</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
          <group group_id="O8">
            <title>Cohort B - 18F-DCFPyL PET/CT: Reader 3</title>
            <description>One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging</title>
          <description>The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.</description>
          <population>The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="252"/>
                <count group_id="O2" value="252"/>
                <count group_id="O3" value="252"/>
                <count group_id="O4" value="252"/>
                <count group_id="O5" value="92"/>
                <count group_id="O6" value="93"/>
                <count group_id="O7" value="93"/>
                <count group_id="O8" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tissue Site: Bone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="251"/>
                    <count group_id="O2" value="252"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                    <count group_id="O7" value="93"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of Lesions: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="234"/>
                    <measurement group_id="O3" value="247"/>
                    <measurement group_id="O4" value="237"/>
                    <measurement group_id="O5" value="37"/>
                    <measurement group_id="O6" value="22"/>
                    <measurement group_id="O7" value="28"/>
                    <measurement group_id="O8" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="20"/>
                    <measurement group_id="O6" value="21"/>
                    <measurement group_id="O7" value="24"/>
                    <measurement group_id="O8" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: &gt;6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="37"/>
                    <measurement group_id="O7" value="32"/>
                    <measurement group_id="O8" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tissue Site: Visceral/Soft Tissue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="251"/>
                    <count group_id="O2" value="252"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                    <count group_id="O7" value="93"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of Lesions: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                    <measurement group_id="O2" value="241"/>
                    <measurement group_id="O3" value="249"/>
                    <measurement group_id="O4" value="240"/>
                    <measurement group_id="O5" value="72"/>
                    <measurement group_id="O6" value="71"/>
                    <measurement group_id="O7" value="73"/>
                    <measurement group_id="O8" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="15"/>
                    <measurement group_id="O7" value="14"/>
                    <measurement group_id="O8" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: &gt;6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tissue Site: Lymph Nodes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="251"/>
                    <count group_id="O2" value="252"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                    <count group_id="O7" value="93"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of Lesions: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="216"/>
                    <measurement group_id="O3" value="226"/>
                    <measurement group_id="O4" value="218"/>
                    <measurement group_id="O5" value="37"/>
                    <measurement group_id="O6" value="38"/>
                    <measurement group_id="O7" value="37"/>
                    <measurement group_id="O8" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="25"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="16"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="13"/>
                    <measurement group_id="O8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: &gt;6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="29"/>
                    <measurement group_id="O7" value="23"/>
                    <measurement group_id="O8" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tissue Site: Prostate Gland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="250"/>
                    <count group_id="O2" value="252"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                    <count group_id="O5" value="91"/>
                    <count group_id="O6" value="93"/>
                    <count group_id="O7" value="93"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of Lesions: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="79"/>
                    <measurement group_id="O6" value="64"/>
                    <measurement group_id="O7" value="69"/>
                    <measurement group_id="O8" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="199"/>
                    <measurement group_id="O3" value="209"/>
                    <measurement group_id="O4" value="204"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="20"/>
                    <measurement group_id="O7" value="22"/>
                    <measurement group_id="O8" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: &gt;6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tissue Site: All</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="252"/>
                    <count group_id="O2" value="252"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="252"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                    <count group_id="O7" value="93"/>
                    <count group_id="O8" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Number of Lesions: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="174"/>
                    <measurement group_id="O3" value="196"/>
                    <measurement group_id="O4" value="175"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="15"/>
                    <measurement group_id="O7" value="17"/>
                    <measurement group_id="O8" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="47"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: 5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number of Lesions: &gt;6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="50"/>
                    <measurement group_id="O6" value="56"/>
                    <measurement group_id="O7" value="46"/>
                    <measurement group_id="O8" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1097</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1087</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1949</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1315</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1977</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Bone</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2149</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2582</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3588</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8791</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9457</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Visceral/Soft tissue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2705</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5933</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7094</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Tissue Type: Lymph nodes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5424</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0038</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0647</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: Prostate Gland</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0021</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0815</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7507</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Tissue Site: All</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5620</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NPV was 0 - no participant had negative histology in the prostate.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NPV was 0 - no participant had negative histology in the prostate.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NPV was 0 - no participant had negative histology in the prostate.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7" lower_limit="69.7" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" lower_limit="69.9" upper_limit="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1" lower_limit="63.8" upper_limit="92.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</title>
        <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
        <time_frame>Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.</time_frame>
        <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
        <group_list>
          <group group_id="O1">
            <title>High Risk Prostate Cancer (Cohort A)</title>
            <description>High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)</title>
          <description>Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.</description>
          <population>The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="252"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8" lower_limit="78.9" upper_limit="88.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4" lower_limit="76.4" upper_limit="86.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" lower_limit="78.2" upper_limit="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
        <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.</description>
        <time_frame>Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.</time_frame>
        <population>The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.</population>
        <group_list>
          <group group_id="O1">
            <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
            <description>Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
          <description>Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.</description>
          <population>The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Reader 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.2" lower_limit="72.9" upper_limit="89.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.9" lower_limit="73.7" upper_limit="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central Reader 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8" lower_limit="80.4" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants</title>
        <time_frame>Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.</time_frame>
        <population>Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)</title>
            <description>A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants</title>
          <population>Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.</population>
          <units>µCi/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants</title>
        <time_frame>Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.</time_frame>
        <population>Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)</title>
            <description>A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants</title>
          <population>Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.</population>
          <units>h*μCi/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>High Risk Prostate Cancer (Cohort A)</title>
          <description>Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
        <group group_id="E2">
          <title>Recurrent or Metastatic Prostate Cancer (Cohort B)</title>
          <description>Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lower gastrointestinal haemmorhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>pyelonephritis, acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Study results cannot be published before the earlier of a multi-site publication; or 18 months after the end of the Study at all sites; or confirmation by Sponsor that there will be no multi-site publication. The proposed publication must be submitted to Sponsor at least 60 days prior to publication so that Sponsor can delete Sponsor Confidential Information (other than Study results) and obtain a further 60 days to file on any invention disclosed in the proposed publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Myl</name_or_title>
      <organization>Lantheus Medical Imaging / Progenics Pharmaceuticals</organization>
      <phone>914-582-1120</phone>
      <email>david.myl@lantheus.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981368
org study id: PyL 2301
nct id: NCT02981368
lead sponsor: 
has dmc: No
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in
      patients with at least high risk prostate cancer who are planned for radical prostatectomy
      with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease
      willing to undergo biopsy (Cohort B).

      Cohort B is complete and no longer recruiting subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
measure: Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
measure: Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
description: Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
measure: Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
description: Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
measure: Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
time frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
measure: Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
description: Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).
measure: Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
time frame: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
description: The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
measure: Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
measure: Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
description: Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
description: Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.
measure: Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
arm group label: 18F-DCFPyL Injection
arm group type: Experimental
description: 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
intervention type: Drug
intervention name: 18F-DCFPyL Injection
description: A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
arm group label: 18F-DCFPyL Injection
other name: PyL
intervention type: Diagnostic Test
intervention name: PET/CT imaging
description: PET/CT imaging will be acquired 1-2 hours post-PyL injection
arm group label: 18F-DCFPyL Injection
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Morris, MD
role: Study Chair
affiliation: Memorial Sloan Kettering Cancer Center
last name: Kenneth J Pienta, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 