<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/NCT02190279</url>
  </required_header>
  <id_info>
    <org_study_id>140140</org_study_id>
    <secondary_id>14-C-0140</secondary_id>
    <nct_id>NCT02190279</nct_id>
  </id_info>
  <brief_title>18F-DCFBC PET/CT in Prostate Cancer</brief_title>
  <official_title>A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</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>
      Background:&#xD;
&#xD;
      - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical&#xD;
      called a radiotracer helps doctors get images of this type of cancer. Researchers want to&#xD;
      test a radiotracer called&#xD;
      N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)&#xD;
      (18F-DCFBC).&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have&#xD;
      relapsed, or has spread outside the prostate.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with physical exam and medical history. They will give a&#xD;
           blood sample.&#xD;
&#xD;
        -  Participants will be divided into three groups.&#xD;
&#xD;
      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or&#xD;
      biopsy at National Institutes of Health (NIH).&#xD;
&#xD;
      Group 2: people who had their prostate removed or had radiation therapy and now have a rising&#xD;
      prostate-specific antigen (PSA) without other signs of disease.&#xD;
&#xD;
      Group 3: people whose cancer has spread to other areas of the body.&#xD;
&#xD;
        -  Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission&#xD;
           tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on&#xD;
           their back on the scanner table.&#xD;
&#xD;
        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the&#xD;
           rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a&#xD;
           contrast agent injected through an intravenous line.&#xD;
&#xD;
        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21&#xD;
           days of the 18F-DCFBC scan to look for prostate cancer in the bone.&#xD;
&#xD;
        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.&#xD;
&#xD;
        -  A few days after each scan, participants will be contacted for follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
        -  Prostate cancer is the second leading cause of cancer deaths in American men.&#xD;
&#xD;
        -  Current methods of imaging advanced prostate cancer (computed tomography ((CT) and bone&#xD;
           scan) are non specific and new, more specific molecular imaging probes are sought.&#xD;
&#xD;
        -  Many prostate cancers express the prostate specific membrane antigen (PSMA) a&#xD;
           transmembrane protein with N-acetylated alpha-linked acidic dipeptidase (NAALADase)&#xD;
           enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited&#xD;
           expression in normal tissue.&#xD;
&#xD;
        -  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)&#xD;
           (18F-DCFBC) is a radiolabeled positron emission tomography (PET) agent which binds with&#xD;
           high affinity to PSMA and through whole-body non-invasive functional imaging, may&#xD;
           provide new information on the expression of PSMA.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      - To assess the ability of 18F-DCFBC to differentiate between tumorous and nontumorous&#xD;
      tissues in localized, recurrent (based on rising prostatic-specific antigen ((PSA) post&#xD;
      treatment) and metastatic prostate cancer&#xD;
&#xD;
      Eligibility&#xD;
&#xD;
        -  Subject is greater than or equal to 18 years old&#xD;
&#xD;
        -  Eastern Cooperative Oncology Group (ECOG) 0-2 with adenocarcinoma of the prostate and&#xD;
           fits criteria for one of the following:&#xD;
&#xD;
        -  ARM 1&#xD;
&#xD;
           -- Patients with known localized prostate cancer with a soft tissue lesion at least 6mm&#xD;
           or greater.&#xD;
&#xD;
           ---A multiparametric magnetic resonance imaging (MRI) (standard of care at the National&#xD;
           Institutes of Health ((NIH) Clinical Center) must be performed within 4 months&#xD;
           of18F-DCFBC injection with findings suggestive for prostate cancer and confirmed with&#xD;
           histopathology.&#xD;
&#xD;
        -  ARM 2&#xD;
&#xD;
             -  Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
&#xD;
                  -  For patients status post radiation therapy for prostate cancer, a PSA increase&#xD;
                     from post radiation therapy nadir&#xD;
&#xD;
                  -  OR&#xD;
&#xD;
                  -  For patients status post prostatectomy, any PSA &gt;/=0.2 ng/ml&#xD;
&#xD;
             -  Nonspecific or no evidence for disease on standard imaging modality&#xD;
&#xD;
        -  ARM 3&#xD;
&#xD;
             -  Patients with identifiable metastatic disease on a conventional imaging modality.&#xD;
                If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients&#xD;
                must have confirmation of prostate cancer prior to 18F-DCFBC imaging.&#xD;
&#xD;
      Design&#xD;
&#xD;
      This is a single site 3-arm study enrolling a total of 110 evaluable patients: Arm 1 will&#xD;
      include 12 patients with presumed localized prostate cancer scheduled to undergo&#xD;
      prostatectomy or biopsy within 4 months of enrollment; Arm 2 will include 78 patients with&#xD;
      biochemical recurrence without evidence of metastasis on conventional imaging; and Arm 3 will&#xD;
      include 20 patients with known metastatic disease who may or may not be on or/scheduled to&#xD;
      begin therapeutic intervention. Patients with presumed localized disease will undergo a&#xD;
      standard of care, clinical multiparametric endorectal coil MRI in the National Cancer&#xD;
      Institute (NCI) Molecular Imaging Clinic within 4 months of screening. Patients in Arm 3 will&#xD;
      undergo 2 imaging sessions: baseline and 4-6 month follow-up. Clinical records (including&#xD;
      PSA) and treatment (if any) that occurred in the imaging interval must be available. All&#xD;
      patients in Arm 3 will also undergo Na18F PET/CT for evaluation of bone metastases as part of&#xD;
      this protocol. In order to allow for a small number of nonevaluable patients, the accrual&#xD;
      ceiling will be set at 125.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2014</start_date>
  <completion_date type="Actual">January 11, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging</measure>
    <time_frame>1 hour and 2 hour timepoints at baseline</time_frame>
    <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)</measure>
    <time_frame>1 hour and 2 hour timepoints at baseline</time_frame>
    <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)</measure>
    <time_frame>Date treatment consent signed to date off study, approximately 42 months and 21 days</time_frame>
    <description>Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease</measure>
    <time_frame>3 months</time_frame>
    <description>18F-DFBC and conventional imaging was used to identify positive lesions in bone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)</measure>
    <time_frame>1 hour and 2 hour post injection (p.i.)</time_frame>
    <description>Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy</measure>
    <time_frame>1 month</time_frame>
    <description>Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland</measure>
    <time_frame>3 months</time_frame>
    <description>Visualizing positive lesions with DCFBC and mpMRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group</measure>
    <time_frame>3 months</time_frame>
    <description>Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Suspected Localized Prostate Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biochemical Recurrence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with biochemical prostate cancer relapse after definitive treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Known Metastatic Disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F DCFBC</intervention_name>
    <description>Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
    <arm_group_label>Biochemical Recurrence</arm_group_label>
    <arm_group_label>Known Metastatic Disease</arm_group_label>
    <arm_group_label>Suspected Localized Prostate Cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)</intervention_name>
    <arm_group_label>Known Metastatic Disease</arm_group_label>
    <other_name>Na 18F PET/CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Subject is greater than or equal to18 years old&#xD;
&#xD;
          -  Platelet count &gt; 50,000/mm^3&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.&#xD;
&#xD;
          -  Ability to provide informed consent. All subjects must sign an informed consent form&#xD;
             indicating their understanding of the investigational nature and risks of the study&#xD;
             before any protocol-related studies are performed.&#xD;
&#xD;
          -  Categories&#xD;
&#xD;
               -  ARM 1 only&#xD;
&#xD;
                  ---For patients with presumed localized disease (any tumor (T), nodes 0 (N0),&#xD;
                  metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI)&#xD;
                  (standard of care at the National Institutes of Health ((NIH) Clinical Center)&#xD;
                  must be performed within 4 months of the&#xD;
                  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine&#xD;
                  ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer&#xD;
                  and a prostate lesion at least 6mm or greater. Must have histopathologic&#xD;
                  confirmation of prostate cancer prior to 18F-DCFBC imaging.&#xD;
&#xD;
               -  ARM 2 only:&#xD;
&#xD;
                    -  For patients status post radiation therapy for prostate cancer, any&#xD;
                       prostatic-specific antigen (PSA) increase from post radiation therapy nadir&#xD;
&#xD;
                    -  OR&#xD;
&#xD;
                    -  For patients status post prostatectomy, a PSA &gt;/=0.2 ng/ml&#xD;
&#xD;
                    -  Nonspecific or no evidence for disease on standard imaging modality&#xD;
&#xD;
               -  ARM 3 only:&#xD;
&#xD;
                    -  Patients must have identifiable metastatic disease on at least 1 clinically&#xD;
                       indicated imaging modality. If only soft tissue metastasis, one lesion must&#xD;
                       measure at least 6mm or greater. Patients must have confirmation of prostate&#xD;
                       cancer prior to 18FDCFBC imaging&#xD;
&#xD;
        Note: A patient who is eligible for one arm, subsequently may cross-over into a different&#xD;
        arm.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Subjects for whom participating would significantly delay the scheduled standard of&#xD;
             care therapy&#xD;
&#xD;
          -  Subjects with any coexisting medical or psychiatric condition that is likely to&#xD;
             interfere with study procedures and/or results.&#xD;
&#xD;
          -  Subjects with severe claustrophobia unresponsive to oral anxiolytics&#xD;
&#xD;
          -  Other medical conditions deemed by the principal investigator (or associates) to make&#xD;
             the subject unsafe/ineligible for protocol procedures.&#xD;
&#xD;
          -  Subjects weighing &gt; 350 lbs. (weight limit for scanner table), or unable to fit within&#xD;
             the imaging gantry&#xD;
&#xD;
          -  Serum creatinine &gt; 2 times the upper limit of normal&#xD;
&#xD;
          -  Total bilirubin &gt; 2 times the upper limit of normal&#xD;
&#xD;
          -  Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST))&#xD;
             greater than 3 times the upper limit of normal&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Liza Lindenberg, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-C-0140.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <results_reference>
    <citation>Mena E, Lindenberg ML, Shih JH, Adler S, Harmon S, Bergvall E, Citrin D, Dahut W, Ton AT, McKinney Y, Weaver J, Eclarinal P, Forest A, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Pinto P, Wood BJ, Jacobs P, Pomper MG, Choyke PL, Turkbey B. Clinical impact of PSMA-based 18F-DCFBC PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. Eur J Nucl Med Mol Imaging. 2018 Jan;45(1):4-11. doi: 10.1007/s00259-017-3818-x. Epub 2017 Sep 11.</citation>
    <PMID>28894899</PMID>
  </results_reference>
  <results_reference>
    <citation>Turkbey B, Mena E, Lindenberg L, Adler S, Bednarova S, Berman R, Ton AT, McKinney Y, Eclarinal P, Hill C, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Jacobs PM, Wood BJ, Pinto PA, Pomper MG, Choyke PL. 18F-DCFBC Prostate-Specific Membrane Antigen-Targeted PET/CT Imaging in Localized Prostate Cancer: Correlation With Multiparametric MRI and Histopathology. Clin Nucl Med. 2017 Oct;42(10):735-740. doi: 10.1097/RLU.0000000000001804.</citation>
    <PMID>28806263</PMID>
  </results_reference>
  <results_reference>
    <citation>Harmon SA, Bergvall E, Mena E, Shih JH, Adler S, McKinney Y, Mehralivand S, Citrin DE, Couvillon A, Madan RA, Gulley JL, Mease RC, Jacobs PM, Pomper MG, Turkbey B, Choyke PL, Lindenberg ML. A Prospective Comparison of 18F-Sodium Fluoride PET/CT and PSMA-Targeted 18F-DCFBC PET/CT in Metastatic Prostate Cancer. J Nucl Med. 2018 Nov;59(11):1665-1671. doi: 10.2967/jnumed.117.207373. Epub 2018 Mar 30.</citation>
    <PMID>29602821</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>December 21, 2018</results_first_submitted>
  <results_first_submitted_qc>April 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2019</results_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Institute (NCI)</investigator_affiliation>
    <investigator_full_name>Maria Liza Lindenberg, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate Specific Membrane Antigen</keyword>
  <keyword>Radiolabeled PET Agent</keyword>
  <keyword>Imaging</keyword>
  <keyword>NaF</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 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>December 27, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02190279/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 14, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02190279/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Suspected Localized Prostate Cancer</title>
          <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="P2">
          <title>Biochemical Recurrence</title>
          <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="P3">
          <title>Known Metastatic Disease</title>
          <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused further treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screening failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Suspected Localized Prostate Cancer</title>
          <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="B2">
          <title>Biochemical Recurrence</title>
          <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="B3">
          <title>Known Metastatic Disease</title>
          <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="B4">
          <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="16"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="116"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.58" spread="8.53"/>
                    <measurement group_id="B2" value="65.33" spread="6.67"/>
                    <measurement group_id="B3" value="63.93" spread="11.41"/>
                    <measurement group_id="B4" value="64.85" spread="8.38"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="116"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gleason Grade at Diagnosis</title>
          <description>Gleason grades help determine a good or bad prognosis for a with prostate cancer. Grade 5-6 are low on the scale and can indicate a less aggressive cancer. A higher number such as Grade 7-10 means a more aggressive cancer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gleason Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gleason Grade 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gleason Grade 7-8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gleason Grade 9-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Prostate Cancer Therapy</title>
          <description>Androgen deprivation therapy (ADT). Radium 223 (Ra223).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radical Prostatectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brachytherapy/Radiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADT + Surgery or Radiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADT + Chemotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Combo radical prostectomy and radiation therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Imaging</title>
          <description>N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Positron emission tomography (PET) Computed tomography (CT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>NaF PET/CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DCFBC(1h) PET/CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DCFBC(2h) PET/CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prostatic-Specific Antigen (PSA) at Baseline</title>
          <description>Normal PSA is defined as less than 4.0 ng/ml.</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.5" lower_limit="3.26" upper_limit="216"/>
                    <measurement group_id="B2" value="1.63" lower_limit="0.2" upper_limit="37.4"/>
                    <measurement group_id="B3" value="1.90" lower_limit="0.01" upper_limit="4379"/>
                    <measurement group_id="B4" value="13.67" lower_limit="1.15" upper_limit="1544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Castration Status</title>
          <description>Castrate sensitive is defined as cancer that is outside the boundary of the prostate. Castrate resistant is defined as cancer of the prostate that no longer responds to one of the most common types of prostate treatment known as androgen deprivation therapy (ADT) (i.e. lowers testosterone levels).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Untreated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Castrate-sensitive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Castrate-resistant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging</title>
        <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.</description>
        <time_frame>1 hour and 2 hour timepoints at baseline</time_frame>
        <population>In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.&#xD;
Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent</population>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O2">
            <title>Biochemical Recurrence</title>
            <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O3">
            <title>Known Metastatic Disease</title>
            <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging</title>
          <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.</description>
          <population>In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.&#xD;
Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent</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="13"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lymph nodes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distant sites</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prostate bed/anastomosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)</title>
        <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.</description>
        <time_frame>1 hour and 2 hour timepoints at baseline</time_frame>
        <population>In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.&#xD;
Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent</population>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O2">
            <title>Biochemical Recurrence</title>
            <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O3">
            <title>Known Metastatic Disease</title>
            <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)</title>
          <description>Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.</description>
          <population>In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.&#xD;
Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent</population>
          <units>lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)</title>
        <description>Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
        <time_frame>Date treatment consent signed to date off study, approximately 42 months and 21 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O2">
            <title>Biochemical Recurrence</title>
            <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
          <group group_id="O3">
            <title>Known Metastatic Disease</title>
            <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)</title>
          <description>Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease</title>
        <description>18F-DFBC and conventional imaging was used to identify positive lesions in bone.</description>
        <time_frame>3 months</time_frame>
        <population>The Suspected Localized Prostate Cancer and Biochemical Recurrence Arms/Groups are not applicable for this outcome measure, thus are not represented here. Data was collected for 31 participants but only 28 had data evaluable for final analysis in the Known Metastatic Group.</population>
        <group_list>
          <group group_id="O1">
            <title>Known Metastatic Disease</title>
            <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease</title>
          <description>18F-DFBC and conventional imaging was used to identify positive lesions in bone.</description>
          <population>The Suspected Localized Prostate Cancer and Biochemical Recurrence Arms/Groups are not applicable for this outcome measure, thus are not represented here. Data was collected for 31 participants but only 28 had data evaluable for final analysis in the Known Metastatic Group.</population>
          <units>number of bone lesions</units>
          <param>Number</param>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)</title>
        <description>Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.</description>
        <time_frame>1 hour and 2 hour post injection (p.i.)</time_frame>
        <population>3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)</title>
          <description>Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.</description>
          <population>3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
          <units>standardized uptake value (SUV)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Primary prostate tumor - 1 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BPH nodules - 1 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal prostate - 1 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary prostate tumor - 2 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BPH nodules - 2 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal prostate tumor - 2 hour post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>At 1 hour post injection.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0033</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>At 2 hour post injection.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy</title>
        <description>Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.</description>
        <time_frame>1 month</time_frame>
        <population>3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy</title>
          <description>Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.</description>
          <population>3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <units_analyzed>Tumor foci</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Tumor foci</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.6" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>One way analysis variance.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>variance</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland</title>
        <description>Visualizing positive lesions with DCFBC and mpMRI.</description>
        <time_frame>3 months</time_frame>
        <population>3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
        <group_list>
          <group group_id="O1">
            <title>Suspected Localized Prostate Cancer</title>
            <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland</title>
          <description>Visualizing positive lesions with DCFBC and mpMRI.</description>
          <population>3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.</population>
          <units>percent of lesions identified</units>
          <param>Number</param>
          <units_analyzed>lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>18F-DCFBC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mpMRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group</title>
        <description>Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.</description>
        <time_frame>3 months</time_frame>
        <population>1 patient had technical issues and was not included in the final analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Biochemical Recurrence</title>
            <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
          </group>
        </group_list>
        <measure>
          <title>Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group</title>
          <description>Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.</description>
          <population>1 patient had technical issues and was not included in the final analysis.</population>
          <units>percent of tumors identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;0.5 ng/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0.5 to &lt;1.0 ng/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.0 to 2.0 ng/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.0 ng/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Date treatment consent signed to date off study, approximately 42 months and 21 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Suspected Localized Prostate Cancer</title>
          <description>Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.&#xD;
N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="E2">
          <title>Biochemical Recurrence</title>
          <description>Patients with biochemical prostate cancer relapse after definitive treatment&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
        <group group_id="E3">
          <title>Known Metastatic Disease</title>
          <description>Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.&#xD;
18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders - Other, nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <description>Death due to progressive disease</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>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="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Investigations - Other, near syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </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>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. Maria Liza Lindenberg</name_or_title>
      <organization>National Cancer Institute</organization>
      <phone>240-760-6109</phone>
      <email>liza.lindenberg@nih.gov</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/NCT02190279
org study id: 140140
secondary id: 14-C-0140
nct id: NCT02190279
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Background:

      - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical
      called a radiotracer helps doctors get images of this type of cancer. Researchers want to
      test a radiotracer called
      N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
      (18F-DCFBC).

      Objective:

      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.

      Eligibility:

      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have
      relapsed, or has spread outside the prostate.

      Design:

        -  Participants will be screened with physical exam and medical history. They will give a
           blood sample.

        -  Participants will be divided into three groups.

      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or
      biopsy at National Institutes of Health (NIH).

      Group 2: people who had their prostate removed or had radiation therapy and now have a rising
      prostate-specific antigen (PSA) without other signs of disease.

      Group 3: people whose cancer has spread to other areas of the body.

        -  Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission
           tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on
           their back on the scanner table.

        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the
           rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a
           contrast agent injected through an intravenous line.

        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21
           days of the 18F-DCFBC scan to look for prostate cancer in the bone.

        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.

        -  A few days after each scan, participants will be contacted for follow-up.
Background

        -  Prostate cancer is the second leading cause of cancer deaths in American men.

        -  Current methods of imaging advanced prostate cancer (computed tomography ((CT) and bone
           scan) are non specific and new, more specific molecular imaging probes are sought.

        -  Many prostate cancers express the prostate specific membrane antigen (PSMA) a
           transmembrane protein with N-acetylated alpha-linked acidic dipeptidase (NAALADase)
           enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited
           expression in normal tissue.

        -  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
           (18F-DCFBC) is a radiolabeled positron emission tomography (PET) agent which binds with
           high affinity to PSMA and through whole-body non-invasive functional imaging, may
           provide new information on the expression of PSMA.

      Primary Objective

      - To assess the ability of 18F-DCFBC to differentiate between tumorous and nontumorous
      tissues in localized, recurrent (based on rising prostatic-specific antigen ((PSA) post
      treatment) and metastatic prostate cancer

      Eligibility

        -  Subject is greater than or equal to 18 years old

        -  Eastern Cooperative Oncology Group (ECOG) 0-2 with adenocarcinoma of the prostate and
           fits criteria for one of the following:

        -  ARM 1

           -- Patients with known localized prostate cancer with a soft tissue lesion at least 6mm
           or greater.

           ---A multiparametric magnetic resonance imaging (MRI) (standard of care at the National
           Institutes of Health ((NIH) Clinical Center) must be performed within 4 months
           of18F-DCFBC injection with findings suggestive for prostate cancer and confirmed with
           histopathology.

        -  ARM 2

             -  Patients with biochemical prostate cancer relapse after definitive treatment

                  -  For patients status post radiation therapy for prostate cancer, a PSA increase
                     from post radiation therapy nadir

                  -  OR

                  -  For patients status post prostatectomy, any PSA >/=0.2 ng/ml

             -  Nonspecific or no evidence for disease on standard imaging modality

        -  ARM 3

             -  Patients with identifiable metastatic disease on a conventional imaging modality.
                If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients
                must have confirmation of prostate cancer prior to 18F-DCFBC imaging.

      Design

      This is a single site 3-arm study enrolling a total of 110 evaluable patients: Arm 1 will
      include 12 patients with presumed localized prostate cancer scheduled to undergo
      prostatectomy or biopsy within 4 months of enrollment; Arm 2 will include 78 patients with
      biochemical recurrence without evidence of metastasis on conventional imaging; and Arm 3 will
      include 20 patients with known metastatic disease who may or may not be on or/scheduled to
      begin therapeutic intervention. Patients with presumed localized disease will undergo a
      standard of care, clinical multiparametric endorectal coil MRI in the National Cancer
      Institute (NCI) Molecular Imaging Clinic within 4 months of screening. Patients in Arm 3 will
      undergo 2 imaging sessions: baseline and 4-6 month follow-up. Clinical records (including
      PSA) and treatment (if any) that occurred in the imaging interval must be available. All
      patients in Arm 3 will also undergo Na18F PET/CT for evaluation of bone metastases as part of
      this protocol. In order to allow for a small number of nonevaluable patients, the accrual
      ceiling will be set at 125.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging
time frame: 1 hour and 2 hour timepoints at baseline
description: Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.
measure: Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
time frame: 1 hour and 2 hour timepoints at baseline
description: Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.
measure: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
time frame: Date treatment consent signed to date off study, approximately 42 months and 21 days
description: Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
measure: Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease
time frame: 3 months
description: 18F-DFBC and conventional imaging was used to identify positive lesions in bone.
measure: Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)
time frame: 1 hour and 2 hour post injection (p.i.)
description: Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.
measure: Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy
time frame: 1 month
description: Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.
measure: Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland
time frame: 3 months
description: Visualizing positive lesions with DCFBC and mpMRI.
measure: Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group
time frame: 3 months
description: Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.
arm group label: Suspected Localized Prostate Cancer
arm group type: Experimental
description: Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.
arm group label: Biochemical Recurrence
arm group type: Experimental
description: Patients with biochemical prostate cancer relapse after definitive treatment
arm group label: Known Metastatic Disease
arm group type: Experimental
description: Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.
intervention type: Drug
intervention name: 18F DCFBC
description: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
arm group label: Biochemical Recurrence
arm group label: Known Metastatic Disease
arm group label: Suspected Localized Prostate Cancer
intervention type: Drug
intervention name: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)
arm group label: Known Metastatic Disease
other name: Na 18F PET/CT
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Maria Liza Lindenberg, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-C-0140.html
description: NIH Clinical Center Detailed Web Page
citation: Mena E, Lindenberg ML, Shih JH, Adler S, Harmon S, Bergvall E, Citrin D, Dahut W, Ton AT, McKinney Y, Weaver J, Eclarinal P, Forest A, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Pinto P, Wood BJ, Jacobs P, Pomper MG, Choyke PL, Turkbey B. Clinical impact of PSMA-based 18F-DCFBC PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. Eur J Nucl Med Mol Imaging. 2018 Jan;45(1):4-11. doi: 10.1007/s00259-017-3818-x. Epub 2017 Sep 11.
PMID: 28894899
citation: Turkbey B, Mena E, Lindenberg L, Adler S, Bednarova S, Berman R, Ton AT, McKinney Y, Eclarinal P, Hill C, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Jacobs PM, Wood BJ, Pinto PA, Pomper MG, Choyke PL. 18F-DCFBC Prostate-Specific Membrane Antigen-Targeted PET/CT Imaging in Localized Prostate Cancer: Correlation With Multiparametric MRI and Histopathology. Clin Nucl Med. 2017 Oct;42(10):735-740. doi: 10.1097/RLU.0000000000001804.
PMID: 28806263
citation: Harmon SA, Bergvall E, Mena E, Shih JH, Adler S, McKinney Y, Mehralivand S, Citrin DE, Couvillon A, Madan RA, Gulley JL, Mease RC, Jacobs PM, Pomper MG, Turkbey B, Choyke PL, Lindenberg ML. A Prospective Comparison of 18F-Sodium Fluoride PET/CT and PSMA-Targeted 18F-DCFBC PET/CT in Metastatic Prostate Cancer. J Nucl Med. 2018 Nov;59(11):1665-1671. doi: 10.2967/jnumed.117.207373. Epub 2018 Mar 30.
PMID: 29602821
responsible party type: Principal Investigator
investigator affiliation: National Cancer Institute (NCI)
investigator full name: Maria Liza Lindenberg, M.D.
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 