<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/NCT03803475</url>
  </required_header>
  <id_info>
    <org_study_id>185513</org_study_id>
    <secondary_id>NCI-2019-01394</secondary_id>
    <nct_id>NCT03803475</nct_id>
  </id_info>
  <brief_title>Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients</brief_title>
  <official_title>Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Hope</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are imaging patients with prostate cancer using a new Positron Emission&#xD;
      Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect&#xD;
      prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of&#xD;
      metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on&#xD;
      prostate cancer cells that can be imaged using small molecules that target this protocol. PET&#xD;
      imaging will begin 50-100 minutes after injection, but may be possible in certain&#xD;
      circumstances for imaging to be delayed due to patient workflow or equipment issues&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection&#xD;
      of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging&#xD;
      follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 2020</primary_completion_date>
  <phase>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>Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group</measure>
    <time_frame>1 day</time_frame>
    <description>Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group</measure>
    <time_frame>1 day</time_frame>
    <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group</measure>
    <time_frame>1 day</time_frame>
    <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group</measure>
    <time_frame>1 day</time_frame>
    <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group</measure>
    <time_frame>1 day</time_frame>
    <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">485</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Ga-68 labeled PSMA-11 PET PSMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ga-68 labeled PSMA-11</intervention_name>
    <description>Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.</description>
    <arm_group_label>Ga-68 labeled PSMA-11 PET PSMA</arm_group_label>
    <other_name>Ga-68 labeled DKFZ-PSMA-11</other_name>
    <other_name>Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED- CC</other_name>
    <other_name>Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC</other_name>
    <other_name>Ga-68 labeled HBED-CC PSMA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positron emission tomography-computed tomography (PET/CT)</intervention_name>
    <description>Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session</description>
    <arm_group_label>Ga-68 labeled PSMA-11 PET PSMA</arm_group_label>
    <other_name>PET-CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positron emission tomography-magnetic resonance imaging (PET/MRI)</intervention_name>
    <description>A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session</description>
    <arm_group_label>Ga-68 labeled PSMA-11 PET PSMA</arm_group_label>
    <other_name>PET-MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male, age &gt;= 18.&#xD;
&#xD;
          2. Histopathologically proven prostate adenocarcinoma.&#xD;
&#xD;
          3. Concern for metastatic disease in one of the following settings:&#xD;
&#xD;
               1. Initial staging with intermediate to high risk prostate cancer.&#xD;
&#xD;
               2. Biochemical recurrence after initial therapy.&#xD;
&#xD;
          4. Ability to understand a written informed consent document, and the willingness to sign&#xD;
             it.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patient unlikely to comply with study procedures, restrictions and requirements and&#xD;
        judged by the Investigator to be unsuitable for study participation.&#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>Thomas Hope, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>July 8, 2021</results_first_submitted>
  <results_first_submitted_qc>July 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Thomas Hope</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Edetic Acid</mesh_term>
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03803475/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
          <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="485"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="484"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
          <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="485"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.13" lower_limit="48" upper_limit="92"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="441"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="408"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group</title>
        <description>Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
        <time_frame>1 day</time_frame>
        <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
        <group_list>
          <group group_id="O1">
            <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
            <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
          </group>
        </group_list>
        <measure>
          <title>Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group</title>
          <description>Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
          <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
          <units>proportion</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="484"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA Level of 0 to 0.19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.2 to 0.49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.5 to 0.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 1 to 1.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 2 to 4.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 5 to maximum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group</title>
        <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
        <time_frame>1 day</time_frame>
        <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
        <group_list>
          <group group_id="O1">
            <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
            <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
          </group>
        </group_list>
        <measure>
          <title>Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group</title>
          <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
          <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
          <units>proportion</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="484"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA Level of 0 to 0.19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.2 to 0.49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.5 to 0.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 1 to 1.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 2 to 4.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 5 to maximum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group</title>
        <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
        <time_frame>1 day</time_frame>
        <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
        <group_list>
          <group group_id="O1">
            <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
            <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
          </group>
        </group_list>
        <measure>
          <title>Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group</title>
          <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
          <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
          <units>proportion</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="484"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA Level of 0 to 0.19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.2 to 0.49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.5 to 0.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 1 to 1.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 2 to 4.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 5 to maximum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group</title>
        <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
        <time_frame>1 day</time_frame>
        <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
        <group_list>
          <group group_id="O1">
            <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
            <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
          </group>
        </group_list>
        <measure>
          <title>Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group</title>
          <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
          <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
          <units>proportion</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="484"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA Level of 0 to 0.19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.2 to 0.49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.5 to 0.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 1 to 1.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 2 to 4.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 5 to maximum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group</title>
        <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
        <time_frame>1 day</time_frame>
        <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
        <group_list>
          <group group_id="O1">
            <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
            <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
          </group>
        </group_list>
        <measure>
          <title>Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group</title>
          <description>Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.</description>
          <population>The Number Analyzed for each Row indicates the number of participants with each detected level of PSA</population>
          <units>proportion</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="484"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA Level of 0 to 0.19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.2 to 0.49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 0.5 to 0.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 1 to 1.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 2 to 4.99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA Level of 5 to maximum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ga-68 Labeled PSMA-11 PET PSMA</title>
          <description>Participants will receive the imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) administered in a single time intravenously prior to the Positron emission tomography (PET) imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.</description>
        </group>
      </group_list>
      <serious_events>
        <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="485"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Thomas Hope, MD</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>(415) 221-4810</phone>
      <email>Thomas.Hope@ucsf.edu</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/NCT03803475
org study id: 185513
secondary id: NCI-2019-01394
nct id: NCT03803475
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The investigators are imaging patients with prostate cancer using a new Positron Emission
      Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect
      prostate cancer.
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of
      metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on
      prostate cancer cells that can be imaged using small molecules that target this protocol. PET
      imaging will begin 50-100 minutes after injection, but may be possible in certain
      circumstances for imaging to be delayed due to patient workflow or equipment issues

      Primary Objective:

      Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection
      of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging
      follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
time frame: 1 day
description: Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
measure: Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
time frame: 1 day
description: Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
measure: Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
time frame: 1 day
description: Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
measure: Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
time frame: 1 day
description: Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
measure: Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
time frame: 1 day
description: Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
arm group label: Ga-68 labeled PSMA-11 PET PSMA
arm group type: Experimental
description: The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
intervention type: Drug
intervention name: Ga-68 labeled PSMA-11
description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
arm group label: Ga-68 labeled PSMA-11 PET PSMA
other name: Ga-68 labeled DKFZ-PSMA-11
other name: Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED- CC
other name: Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC
other name: Ga-68 labeled HBED-CC PSMA
intervention type: Device
intervention name: Positron emission tomography-computed tomography (PET/CT)
description: Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
arm group label: Ga-68 labeled PSMA-11 PET PSMA
other name: PET-CT
intervention type: Device
intervention name: Positron emission tomography-magnetic resonance imaging (PET/MRI)
description: A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
arm group label: Ga-68 labeled PSMA-11 PET PSMA
other name: PET-MRI
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Hope, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Thomas Hope
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
mesh term: Edetic Acid
mesh term: Gallium 68 PSMA-11
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 