<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/NCT01666808</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00057680</org_study_id>
    <secondary_id>1R01CA169188-01</secondary_id>
    <nct_id>NCT01666808</nct_id>
  </id_info>
  <brief_title>FACBC Outcomes for Post Prostatectomy</brief_title>
  <official_title>Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators will perform a study with 162 patients in whom there is a strong suspicion of&#xD;
      prostate cancer that has returned to the body after having a prostatectomy. Half of these&#xD;
      patients will have radiotherapy decision-making and delivery per the usual routine, and half&#xD;
      of these patients will have the radiotherapy decision and volumes guided by the FACBC test&#xD;
      (anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3- [18F]FACBC). The major goal&#xD;
      of the investigation is to see whether the FACBC improves the selection and the cancer&#xD;
      control rates of post-surgery patients with a rising PSA who undergo radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most common solid tumor, with approximately 200,000 new cases&#xD;
      diagnosed per year. Several different local therapies are available for treatment, including&#xD;
      surgery and radiotherapy Significant advances have been made in the technical aspects of&#xD;
      surgery and of radiotherapy which have improved both the cancer control outcomes as well as&#xD;
      the morbidity of treatment. Despite these significant advances, approximately 30% of patients&#xD;
      treated with definitive local therapy experience recurrent disease. Recurrent disease after&#xD;
      prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA&#xD;
      level is often of limited use in differentiating local recurrence (ie. recurrence in the&#xD;
      prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).&#xD;
&#xD;
      One PET radiotracer which has shown promise in the staging and restaging of patients with&#xD;
      prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid&#xD;
      (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher&#xD;
      accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with&#xD;
      suspected recurrent prostate carcinoma.&#xD;
&#xD;
      The major goal in this proposed investigation is to use advanced molecular imaging to better&#xD;
      guide post-prostatectomy decision making, in terms of guiding the decision to deliver&#xD;
      radiotherapy, and in terms of the exact areas treated with radiotherapy.&#xD;
&#xD;
      Investigators will perform a study with 162 patients in whom there is a strong suspicion of&#xD;
      prostate cancer that has returned to the body after having a prostatectomy. Half of these&#xD;
      patients will have radiotherapy decision-making and delivery per the usual routine, and half&#xD;
      of these patients will have the radiotherapy decision and volumes guided by the FACBC test.&#xD;
      The major goal of the investigation is to see whether the FACBC improves the selection and&#xD;
      the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">April 18, 2022</completion_date>
  <primary_completion_date type="Actual">April 18, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure-free Survival</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decision Changes Regarding Radiotherapy Versus no Radiotherapy</measure>
    <time_frame>Average of 1 week post-intervention</time_frame>
    <description>Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Changes Regarding Whole-pelvis Versus Local Fields</measure>
    <time_frame>Average of 1 week post-intervention</time_frame>
    <description>Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Decision Changes</measure>
    <time_frame>Average of 1 week post-intervention</time_frame>
    <description>Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Bed Clinical Target Volume (CTV)</measure>
    <time_frame>Average of 1 month post-intervention</time_frame>
    <description>Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate Bed Planning Target Volume (PTV)</measure>
    <time_frame>Average of 1 month post-intervention</time_frame>
    <description>Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTV Dosimetric Endpoints</measure>
    <time_frame>Average of 1 month post-intervention</time_frame>
    <description>Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rectum Dosimetric Endpoints</measure>
    <time_frame>Average of 1 month post-intervention</time_frame>
    <description>Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder Dosimetric Endpoints</measure>
    <time_frame>Average of 1 month post-intervention</time_frame>
    <description>Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Prostate Cancer Index Composite (EPIC) Total Score</measure>
    <time_frame>3-Year post-intervention</time_frame>
    <description>Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>FACBC PET scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional-Only Imaging</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FACBC</intervention_name>
    <description>FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings</description>
    <arm_group_label>FACBC PET scan</arm_group_label>
    <other_name>anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation therapy</intervention_name>
    <description>External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.</description>
    <arm_group_label>Conventional-Only Imaging</arm_group_label>
    <other_name>Intensity-modulated radiotherapy (IMRT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA&#xD;
&#xD;
          -  ECOG/Zubrod Performance Status of 0-2&#xD;
&#xD;
          -  Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis&#xD;
&#xD;
          -  CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic&#xD;
             disease outside of the pelvis&#xD;
&#xD;
          -  Willingness to undergo pelvic radiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to radiotherapy (including active inflammatory bowel disease or&#xD;
             prior pelvic XRT)&#xD;
&#xD;
          -  Inability to undergo anti-3-[18F]FACBC PET-CT&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Metastatic disease outside of pelvis on any imaging or biopsy&#xD;
&#xD;
          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free&#xD;
             for a minimum of 3 years&#xD;
&#xD;
          -  Severe acute co-morbidity, defined as follows:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization in the&#xD;
                  last 3 months&#xD;
&#xD;
               -  Transmural myocardial infarction within the last 6 months&#xD;
&#xD;
               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time&#xD;
                  of registration&#xD;
&#xD;
               -  Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy at the time of registration&#xD;
&#xD;
               -  Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition;&#xD;
                  note, however, that HIV testing is not required for entry into this protocol. The&#xD;
                  need to exclude patients with AIDS from this protocol is necessary because the&#xD;
                  treatments involved in this protocol may be significantly immunosuppressive.&#xD;
                  Protocol-specific requirements may also exclude immunocompromised patients&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashesh B Jani, MD, MSEE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David M Schuster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7.</citation>
    <PMID>33971152</PMID>
  </results_reference>
  <results_reference>
    <citation>Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11.</citation>
    <PMID>35417762</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>April 12, 2023</results_first_submitted>
  <results_first_submitted_qc>July 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2023</results_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Ashesh B Jani</investigator_full_name>
    <investigator_title>Professor &amp; Residency Program Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT01666808/Prot_SAP_001.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>March 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT01666808/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>FACBC PET Scan</title>
          <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
        </group>
        <group group_id="P2">
          <title>Conventional-Only Imaging</title>
          <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No radiotherapy given, due to extrapelvic uptake on PET scan</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FACBC PET Scan</title>
          <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
        </group>
        <group group_id="B2">
          <title>Conventional-Only Imaging</title>
          <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="83"/>
            <count group_id="B2" value="82"/>
            <count group_id="B3" value="165"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="42" upper_limit="75"/>
                    <measurement group_id="B2" value="61" lower_limit="46" upper_limit="78"/>
                    <measurement group_id="B3" value="61" lower_limit="42" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="165"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="104"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gleason score ≥8</title>
          <description>Pathological grade was measured on the prostatectomy specimen. Gleason Grading goes from 2 thru 10, with higher scores being worse prognostically. Gleason scores of 8 and higher are considered high-grade, so this measure was designed to see whether the percentage of high-grade patients was balanced.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ave PSA before radiotherapy</title>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.34" lower_limit="0.19" upper_limit="1.08"/>
                    <measurement group_id="B2" value="0.34" lower_limit="0.13" upper_limit="0.95"/>
                    <measurement group_id="B3" value="0.34" lower_limit="0.17" upper_limit="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Failure-free Survival</title>
        <description>Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>This outcome evaluated the failure-free survival difference (among those who received radiotherapy) between the trial group (in which FACBC PET scan was used) versus the control group (in which conventional-only imaging was used).&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Failure-free Survival</title>
          <description>Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.</description>
          <population>This outcome evaluated the failure-free survival difference (among those who received radiotherapy) between the trial group (in which FACBC PET scan was used) versus the control group (in which conventional-only imaging was used).&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5"/>
                    <measurement group_id="O2" value="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decision Changes Regarding Radiotherapy Versus no Radiotherapy</title>
        <description>Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
        <time_frame>Average of 1 week post-intervention</time_frame>
        <population>This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Decision Changes Regarding Radiotherapy Versus no Radiotherapy</title>
          <description>Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
          <population>This outcome evaluated number of decision changes regarding the overall use of radiotherapy in the FACBC PET scan group only.</population>
          <units>Number of decision changes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decision Changes Regarding Whole-pelvis Versus Local Fields</title>
        <description>Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
        <time_frame>Average of 1 week post-intervention</time_frame>
        <population>This outcome evaluated number of decision changes regarding changes from whole-pelvis to local fields and vice versa (local fields to whole pelvis) in the FACBC PET scan group only.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Decision Changes Regarding Whole-pelvis Versus Local Fields</title>
          <description>Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
          <population>This outcome evaluated number of decision changes regarding changes from whole-pelvis to local fields and vice versa (local fields to whole pelvis) in the FACBC PET scan group only.</population>
          <units>Number of decision changes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Decision Changes</title>
        <description>Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
        <time_frame>Average of 1 week post-intervention</time_frame>
        <population>This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Decision Changes</title>
          <description>Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.</description>
          <population>This outcome evaluated number of all radiotherapy-related decision changes in the FACBC PET scan group only.</population>
          <units>Number of decision changes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate Bed Clinical Target Volume (CTV)</title>
        <description>Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
        <time_frame>Average of 1 month post-intervention</time_frame>
        <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate Bed Clinical Target Volume (CTV)</title>
          <description>Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
          <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.14" spread="45.60"/>
                    <measurement group_id="O2" value="137.18" spread="51.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.61" spread="45.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate Bed Planning Target Volume (PTV)</title>
        <description>Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
        <time_frame>Average of 1 month post-intervention</time_frame>
        <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate Bed Planning Target Volume (PTV)</title>
          <description>Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
          <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324.50" spread="79.82"/>
                    <measurement group_id="O2" value="327.71" spread="88.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329.54" spread="81.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PTV Dosimetric Endpoints</title>
        <description>Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
        <time_frame>Average of 1 month post-intervention</time_frame>
        <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>PTV Dosimetric Endpoints</title>
          <description>Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
          <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>percentage of volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PTV2/PTV, V100% pre PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.98" spread="1.56"/>
                    <measurement group_id="O2" value="96.36" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTV2/PTV, V100% post PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.62" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTV2/PTV, V110% pre PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="7.81"/>
                    <measurement group_id="O2" value="0.42" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PTV2/PTV, V110% post PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rectum Dosimetric Endpoints</title>
        <description>Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
        <time_frame>Average of 1 month post-intervention</time_frame>
        <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Rectum Dosimetric Endpoints</title>
          <description>Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
          <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>percentage of volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rectum, V40 pre PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.01" spread="10"/>
                    <measurement group_id="O2" value="45.03" spread="10.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rectum, V40 post PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.07" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rectum, V65 pre PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.35" spread="7.78"/>
                    <measurement group_id="O2" value="19.31" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rectum, V65 post PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.48" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bladder Dosimetric Endpoints</title>
        <description>Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
        <time_frame>Average of 1 month post-intervention</time_frame>
        <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Bladder Dosimetric Endpoints</title>
          <description>Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.</description>
          <population>Note that no participants were analyzed in the Conventional group Post-PET since they did not receive the PET intervention.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>percentage of volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bladder, V40 pre-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.92" spread="14.94"/>
                    <measurement group_id="O2" value="68.95" spread="18.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bladder, V40 post-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.10" spread="14.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bladder, V65 pre-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.68" spread="17.31"/>
                    <measurement group_id="O2" value="50.99" spread="19.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bladder, V65 post-PET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.29" spread="19.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity</title>
        <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>All patients in both the FACBC PET scan and the Conventional-imaging only groups.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity</title>
          <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.</description>
          <population>All patients in both the FACBC PET scan and the Conventional-imaging only groups.</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="83"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of patients with Acute GU toxicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of patients with Late GU toxicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity</title>
        <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>All patients in both the FACBC PET scan and the Conventional-imaging only groups.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity</title>
          <description>Provider-reported maximum acute (&lt;90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.</description>
          <population>All patients in both the FACBC PET scan and the Conventional-imaging only groups.</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="83"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of patients with Acute GI toxicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of patients with Late GI toxicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score</title>
        <description>Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score</title>
          <description>Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.</description>
          <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EPIC GU-incontinence domain score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.99" spread="3.10"/>
                    <measurement group_id="O2" value="3.50" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EPIC GU - irritative/obstructive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="2.02"/>
                    <measurement group_id="O2" value="2.66" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score</title>
        <description>Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score</title>
          <description>Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
          <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="1.99"/>
                    <measurement group_id="O2" value="1.41" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score</title>
        <description>Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score</title>
          <description>Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.</description>
          <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.04" spread="4.14"/>
                    <measurement group_id="O2" value="7.37" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Prostate Cancer Index Composite (EPIC) Total Score</title>
        <description>Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.</description>
        <time_frame>3-Year post-intervention</time_frame>
        <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>FACBC PET Scan</title>
            <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
          </group>
          <group group_id="O2">
            <title>Conventional-Only Imaging</title>
            <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Prostate Cancer Index Composite (EPIC) Total Score</title>
          <description>Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.</description>
          <population>Radiotherapy-treated patients in both the FACBC PET scan and the Conventional-imaging only groups.&#xD;
FACBC PET Group: 83 enrolled subjects minus 3 withdrawals minus 4 patients not receiving radiotherapy due to PET findings = 76 participants.&#xD;
Conventional Imaging Group: 82 enrolled minus 1 withdrawal = 81 participants.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.90" spread="9.98"/>
                    <measurement group_id="O2" value="17.02" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3-years post-intervention</time_frame>
      <desc>Severe Adverse Events (SAEs) were defined as any provider-reported grade 3 or higher Gastrointestinal [GI] or Genitourinary [GU] toxicity. Acute toxicity was measured &lt;90 days Post-Intervention and late toxicity was measured ≥90 days and up to 3-Years post-intervention.&#xD;
Adverse Events (AE's) were defined as any provider-reported (acute or late) grade 2 toxicity.</desc>
      <group_list>
        <group group_id="E1">
          <title>FACBC PET Scan</title>
          <description>A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.&#xD;
FACBC: FACBC is given intravenously prior to PET scan</description>
        </group>
        <group group_id="E2">
          <title>Conventional-Only Imaging</title>
          <description>A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.</description>
        </group>
      </group_list>
      <serious_events>
        <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="1" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria - Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="83"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Hematuria - Late</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="83"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="71" subjects_at_risk="83"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="83"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" events="49" subjects_affected="49" subjects_at_risk="83"/>
                <counts group_id="E2" events="55" subjects_affected="55" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ashesh Jani</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-3827</phone>
      <email>abjani@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01666808
org study id: IRB00057680
secondary id: 1R01CA169188-01
nct id: NCT01666808
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Investigators will perform a study with 162 patients in whom there is a strong suspicion of
      prostate cancer that has returned to the body after having a prostatectomy. Half of these
      patients will have radiotherapy decision-making and delivery per the usual routine, and half
      of these patients will have the radiotherapy decision and volumes guided by the FACBC test
      (anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3- [18F]FACBC). The major goal
      of the investigation is to see whether the FACBC improves the selection and the cancer
      control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases
      diagnosed per year. Several different local therapies are available for treatment, including
      surgery and radiotherapy Significant advances have been made in the technical aspects of
      surgery and of radiotherapy which have improved both the cancer control outcomes as well as
      the morbidity of treatment. Despite these significant advances, approximately 30% of patients
      treated with definitive local therapy experience recurrent disease. Recurrent disease after
      prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA
      level is often of limited use in differentiating local recurrence (ie. recurrence in the
      prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).

      One PET radiotracer which has shown promise in the staging and restaging of patients with
      prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid
      (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher
      accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with
      suspected recurrent prostate carcinoma.

      The major goal in this proposed investigation is to use advanced molecular imaging to better
      guide post-prostatectomy decision making, in terms of guiding the decision to deliver
      radiotherapy, and in terms of the exact areas treated with radiotherapy.

      Investigators will perform a study with 162 patients in whom there is a strong suspicion of
      prostate cancer that has returned to the body after having a prostatectomy. Half of these
      patients will have radiotherapy decision-making and delivery per the usual routine, and half
      of these patients will have the radiotherapy decision and volumes guided by the FACBC test.
      The major goal of the investigation is to see whether the FACBC improves the selection and
      the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Failure-free Survival
time frame: 3-Year post-intervention
description: Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.
measure: Decision Changes Regarding Radiotherapy Versus no Radiotherapy
time frame: Average of 1 week post-intervention
description: Number of decision changes regarding radiotherapy versus no radiotherapy based on F-Fluciclovine PET/CT guidance. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
measure: Decision Changes Regarding Whole-pelvis Versus Local Fields
time frame: Average of 1 week post-intervention
description: Number of decision changes regarding whole-pelvis versus local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
measure: Total Number of Decision Changes
time frame: Average of 1 week post-intervention
description: Total number of radiotherapy decision changes regarding radiotherapy vs no radiotherapy and regarding whole pelvis vs local fields. This outcome was assessed immediately after the consensus reading of the Fluciclovine PET/CT was completed by nuclear medicine, an average of 1 week post intervention.
measure: Prostate Bed Clinical Target Volume (CTV)
time frame: Average of 1 month post-intervention
description: Absolute volume pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
measure: Prostate Bed Planning Target Volume (PTV)
time frame: Average of 1 month post-intervention
description: Absolute volume were measured pre- vs post-PET. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
measure: PTV Dosimetric Endpoints
time frame: Average of 1 month post-intervention
description: Standard radiotherapy dosimetric endpoints used to evaluate target coverage. Planning target volume (PTV) at V100 and V110 refer to %volume of the structure receiving 100% and 110% of the prescription dose, respectively, pre and post positron emission tomography (PET). This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
measure: Rectum Dosimetric Endpoints
time frame: Average of 1 month post-intervention
description: Standard radiotherapy dosimetric endpoints used to evaluate normal tissue doses, in this case, the rectum. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
measure: Bladder Dosimetric Endpoints
time frame: Average of 1 month post-intervention
description: Standard radiotherapy dosimetric endpoints are used to evaluate normal tissue doses, in this case, the bladder. V40 and V65 refer to the %volume of the structure receiving 40 Gy and 65 Gy, respectively, pre and post positron emission tomography (PET) volumes were compared. This outcome was assessed after radiotherapy treatment planning was completed by radiation oncology, an average of 1 month post-intervention.
measure: Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
time frame: 3-Year post-intervention
description: Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) genitourinary toxicity based on CTCAE v4.0 criteria.
measure: Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
time frame: 3-Year post-intervention
description: Provider-reported maximum acute (<90 days Post-Intervention) and late (≥90 days and up to 3-Years post-intervention) gastrointestinal toxicity ≥ Grade 2 based on CTCAE v4.0 criteria.
measure: Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
time frame: 3-Year post-intervention
description: Patient-reported maximum genitourinary toxicity based on standard EPIC-CP questionnaire. EPIC GU domain score has a total score range 0-12. Higher score correlates with worse outcome. EPIC GU score includes the incontinence domain score and the irritative/obstructive.
measure: Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
time frame: 3-Year post-intervention
description: Patient-reported maximum gastrointestinal toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
measure: Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
time frame: 3-Year post-intervention
description: Patient-reported maximum sexual function toxicity based on standard EPIC-CP questionnaire. Total score range 0-12. Higher score correlates with worse outcome.
measure: Expanded Prostate Cancer Index Composite (EPIC) Total Score
time frame: 3-Year post-intervention
description: Patient-reported maximum overall (genitourinary, gastrointestinal, and sexual function) toxicity based on standard EPIC-CP questionnaire. Total score range 0-60. Higher score correlates with worse outcome.
arm group label: FACBC PET scan
arm group type: Experimental
description: A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
arm group label: Conventional-Only Imaging
arm group type: Active Comparator
description: A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.
intervention type: Drug
intervention name: FACBC
description: FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings
arm group label: FACBC PET scan
other name: anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid
intervention type: Radiation
intervention name: Radiation therapy
description: External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.
arm group label: Conventional-Only Imaging
other name: Intensity-modulated radiotherapy (IMRT)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Ashesh B Jani, MD, MSEE
role: Principal Investigator
affiliation: Emory University
last name: David M Schuster, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
citation: Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7.
PMID: 33971152
citation: Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11.
PMID: 35417762
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Ashesh B Jani
investigator title: Professor & Residency Program Director
mesh term: Prostatic Neoplasms
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 