<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/NCT02260817</url>
  </required_header>
  <id_info>
    <org_study_id>ZM-CCH-40-PTL0114</org_study_id>
    <nct_id>NCT02260817</nct_id>
  </id_info>
  <brief_title>Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer</brief_title>
  <official_title>Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Global Isotopes, LLC d/b/a Zevacor Molecular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Global Isotopes, LLC d/b/a Zevacor Molecular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 3 study will target approximately 100 men over age 18 who have a biochemical&#xD;
      relapse or other evidence of relapse of prostate cancer after primary treatment.&#xD;
&#xD;
      The purpose of this study is to:&#xD;
&#xD;
      A. Provide expanded access the drug 11C-choline.&#xD;
&#xD;
      B. Determine the performance characteristics (sensitivity, specificity, positive predictive&#xD;
      value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and&#xD;
      PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in&#xD;
      patients with biochemical relapse of prostate cancer after primary treatment in a prospective&#xD;
      manner.&#xD;
&#xD;
      C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT&#xD;
      and PET/MRI positive patients through a prospective study.&#xD;
&#xD;
      D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a&#xD;
      multivariable analysis of clinical and pathologic data collected prospectively.&#xD;
&#xD;
      E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline&#xD;
      PET/MRI and the combination of 11C-choline PET/CT and PET/MRI&#xD;
&#xD;
      Study Protocol:&#xD;
&#xD;
        1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.&#xD;
&#xD;
        2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.&#xD;
&#xD;
        3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic&#xD;
           prostate cancer.&#xD;
&#xD;
        4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with&#xD;
           biopsy or surgical pathology when possible, or by response to treatment on subsequent&#xD;
           imaging.&#xD;
&#xD;
        5. Rates of confirmed metastasis between conventional CT and MRI images will be compared&#xD;
           with the 11C-choline PET CT and MRI images.&#xD;
&#xD;
        6. Upon conclusion of each imaging protocol, the referring physician will receive written&#xD;
           documentation of the results. At this time, the patient will be considered off study and&#xD;
           no further follow up is required.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The first arm of this study serves to provide expanded access to 11C-choline injection&#xD;
           as currently defined under the reference listed drug label as an investigational drug in&#xD;
           geographical service areas where 11C-choline is not available. The second arm expands&#xD;
           access as well but also attempts to determine the more effective imaging modality and&#xD;
           conditions between PET/CT and PET/MR.&#xD;
&#xD;
        2. The study will consist of patients who have a biochemical relapse or other evidence of&#xD;
           relapse after primary treatment. The first arm of the study is open to as many patients&#xD;
           who elect to participate in the study that are over the age of 18 and have experienced a&#xD;
           biochemical relapse of prostate cancer after primary treatment. The second arm will&#xD;
           consist of patients who have been treated with radiation therapy, or androgen&#xD;
           suppression and radiation therapy who have a PSA &gt; 2 ng/mL higher than the nadir level.&#xD;
           The nadir level in patients who have been treated with androgen suppression and&#xD;
           radiation therapy is determined after the serum testosterone level has normalized. This&#xD;
           study group will also consist of patients who have been treated with radical&#xD;
           prostatectomy and who have a biochemical relapse defined as a PSA of 0.2 ng/mL confirmed&#xD;
           at that level or higher on a subsequent PSA test 3 months later. This group may consist&#xD;
           of men who have other clinical evidence of relapse such as a suspicious bone scan or CT&#xD;
           scan regardless of PSA kinetics. Patients identified as potential subjects will be&#xD;
           screened against the eligibility criteria as defined above in Section 5.1.&#xD;
&#xD;
        3. Informed consent will be obtained from all participants before any study related&#xD;
           procedures are conducted. Each participant will be informed about the nature of the&#xD;
           study, its purpose, and possible risks. Informed consent will be documented by using the&#xD;
           written informed consent document approved by the local IRB at the Decatur Memorial&#xD;
           Hospital.&#xD;
&#xD;
        4. At the time of referral, patients will be asked to bring their prior records as it&#xD;
           pertains to their prostate cancer history. Data collected from outside records, such as&#xD;
           radiographic studies, previous imaging studies and biopsies will be incorporated into&#xD;
           the study record.&#xD;
&#xD;
        5. Abstracted data for the study record will include:&#xD;
&#xD;
             1. Patient demographics such as age, race, and family history of prostate cancer&#xD;
&#xD;
             2. Risk factors such as finasteride or dutasteride use, and environmental exposure&#xD;
                (eg. Agent orange)&#xD;
&#xD;
             3. Prostate exam results, most recent within last 90 days&#xD;
&#xD;
             4. PSA test results, most current and past&#xD;
&#xD;
             5. Past medical and surgical history&#xD;
&#xD;
             6. Current medications&#xD;
&#xD;
             7. Allergies&#xD;
&#xD;
             8. Pathology reports&#xD;
&#xD;
             9. Imaging reports&#xD;
&#xD;
            10. Date of diagnosis&#xD;
&#xD;
            11. Date(s) of biochemical relapse and coordinating PSA results. Once all records have&#xD;
                been assessed for eligibility, an order for the 11C-choline PET CT scan and MRI&#xD;
                scan will be requested from the referring physician and patient will be scheduled&#xD;
                and given the appropriate prep instructions.&#xD;
&#xD;
        6. Both arms of the study will undergo a 11C-choline PET CT scan and MRI scan. The CT scan&#xD;
           will be performed with intravenous contrast unless deemed unsafe by lab values. The CT&#xD;
           and MRI images will be evaluated for evidence of metastatic prostate cancer. The&#xD;
           11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate&#xD;
           cancer. Unequivocal evidence of metastasis on both conventional imaging and 11C-choline&#xD;
           PET will be considered a true positive. Evidence of metastasis on conventional imaging&#xD;
           or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or&#xD;
           by response to treatment on subsequent imaging. If confirmation of metastasis is not&#xD;
           achievable by biopsy or surgical pathology, then confirmation will be achieved with&#xD;
           11C-choline PET CT and MRI images obtained 3 months after treatment conclusion. Rates of&#xD;
           confirmed metastasis between conventional CT and MRI images will be compared with the&#xD;
           11C-choline PET CT and MRI images.&#xD;
&#xD;
        7. Upon conclusion of each imaging protocol, the referring physician will receive written&#xD;
           documentation of the results. At this time, the patient will be considered off study and&#xD;
           no further follow up is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of Metastatic Prostate Cancer</measure>
    <time_frame>After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.</time_frame>
    <description>The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study.&#xD;
True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy.&#xD;
True Negative: True negatives will consist of negative images.&#xD;
False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment.&#xD;
False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of 11C Choline PET Imaging Scans</measure>
    <time_frame>Approximately 1 day post-scan for patient results</time_frame>
    <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity.&#xD;
Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative).&#xD;
This Outcome is only measured for Arm 2 of this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of 11C Choline PET Imaging Scans</measure>
    <time_frame>Approximately 1 day post-scan for patient results</time_frame>
    <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity.&#xD;
Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive).&#xD;
This Outcome is only measured and reported for Arm 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans</measure>
    <time_frame>Approximately 1 day post-scan for patient results</time_frame>
    <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value.&#xD;
Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive).&#xD;
This Outcome is only measured for Arm 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans</measure>
    <time_frame>Approximately 1 day post-scan for patient results</time_frame>
    <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value.&#xD;
Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative).&#xD;
This Outcome is only measured for Arm 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation</measure>
    <time_frame>Approximately 1 day post-scan for patient results</time_frame>
    <description>Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Age at Primary Treatment</measure>
    <time_frame>The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median age at primary treatment for Arm 2 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median PSA at Diagnosis of Arm 2 Participants</measure>
    <time_frame>The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical T (cT) Stage of Arm 2 Participants</measure>
    <time_frame>The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Primary Biopsy Gleason Score of Arm 2 Participants</measure>
    <time_frame>The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.&#xD;
The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.&#xD;
Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).&#xD;
The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.&#xD;
Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Treatment Modality of Arm 2 Participants</measure>
    <time_frame>The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.&#xD;
Modalities reported below are:&#xD;
Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants</measure>
    <time_frame>The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Surgical Margins of Arm 2 Participants</measure>
    <time_frame>The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>A census of the primary surgical margins of participants in Arm 2 will reported.&#xD;
The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.&#xD;
Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Positive Lymph Node Ratio of Arm 2 Participants</measure>
    <time_frame>The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.&#xD;
The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional Treatment and Type for Arm 2 Participants</measure>
    <time_frame>The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.&#xD;
None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Months to Biochemical Relapse of Arm 2 Participants</measure>
    <time_frame>The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Age of Arm 2 Participant at PET Imaging</measure>
    <time_frame>The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median age (at time of study) of participants of Arm 2 will be reported in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median PSA of Arm 2 Participant at PET Imaging</measure>
    <time_frame>The participants' PSA was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median PSA Doubling Time of Arm 2 Participants at PET Imaging</measure>
    <time_frame>The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median PSA Velocity of Arm 2 Participants at PET Imaging</measure>
    <time_frame>The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADT (Androgen Deprivation Therapy) in Participant at PET Imaging</measure>
    <time_frame>The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)</time_frame>
    <description>An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Metastatic Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Expanded Access for 11C-Choline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available.&#xD;
Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>11C-Choline Comparison of Modalities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>11C-choline Injection</intervention_name>
    <description>Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
    <arm_group_label>11C-Choline Comparison of Modalities</arm_group_label>
    <arm_group_label>Expanded Access for 11C-Choline</arm_group_label>
    <other_name>CCH Injection, C11 Choline Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. For biochemical relapse after primary treatment&#xD;
&#xD;
               1. PSA &gt; 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on&#xD;
                  a subsequent test 3 months later&#xD;
&#xD;
               2. PSA increase &gt;2 ng/ml from nadir following radiation therapy&#xD;
&#xD;
               3. PSA increase &gt;2 ng/ml from nadir following radiation therapy plus androgen&#xD;
                  deprivation therapy with nadir defined with normalized testosterone level&#xD;
&#xD;
               4. Two consecutive PSA increases from nadir level after androgen blockade or&#xD;
                  androgen suppression therapy&#xD;
&#xD;
          2. Kidney function with GFR &gt; 60 mL/sec/1.73m2 and Creatinine &lt; 1.7mg, collected within&#xD;
             90 days of planned scan&#xD;
&#xD;
               1. if GFR is &gt; or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast&#xD;
&#xD;
               2. if GFR is &lt; 60 mL/sec/1.73m2, PET/CT will be completed without contrast&#xD;
&#xD;
               3. if Creatinine is &gt; than 1.7 mg, Radiology will follow ACR recommendations as&#xD;
                  outlined in department policy.&#xD;
&#xD;
          3. No known allergy to iodinated radiologic contrast media&#xD;
&#xD;
          4. Able to have MRI based on screening evaluation. If patient is found to be MRI&#xD;
             incompatible, the 11C-choline PET/MRI portion of the study will not be completed.&#xD;
             Please see the provided contact numbers for further options.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ECOG Performance Status &gt; 2.&#xD;
&#xD;
          2. Concurrent malignancy, i.e. colon cancer.&#xD;
&#xD;
          3. Treatment for another malignancy except superficial skin cancer within 5 years&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas H Tarter, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Decatur Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>March 31, 2018</results_first_submitted>
  <results_first_submitted_qc>December 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2019</results_first_posted>
  <last_update_submitted>December 4, 2019</last_update_submitted>
  <last_update_submitted_qc>December 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>11C Choline</keyword>
  <keyword>PET Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 30, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT02260817/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment dates: 10/14 - 6/16, dosage and imaging only at Decatur Memorial Hospital in Decatur, IL.</recruitment_details>
      <pre_assignment_details>No enrolled participants were excluded from either arm of the study prior to assignment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
          <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
        </group>
        <group group_id="P2">
          <title>11C-choline Comparison Study of CT and MR Modalities</title>
          <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="37"/>
              </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="0"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Androgen deprivation therapy, no biopsy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Observation, no biopsy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Biopsy infeasible, ADT &amp; rad. therapy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
          <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
        </group>
        <group group_id="B2">
          <title>11C-choline Comparison Study of CT and MR Modalities</title>
          <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</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="14"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="109"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="46"/>
                  </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="14"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="99"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evidence of Metastatic Prostate Cancer</title>
        <description>The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study.&#xD;
True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy.&#xD;
True Negative: True negatives will consist of negative images.&#xD;
False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment.&#xD;
False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.</description>
        <time_frame>After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.</time_frame>
        <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence of Metastatic Prostate Cancer</title>
          <description>The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study.&#xD;
True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy.&#xD;
True Negative: True negatives will consist of negative images.&#xD;
False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment.&#xD;
False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.</description>
          <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</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="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>True Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>True Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>False Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>False Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity of 11C Choline PET Imaging Scans</title>
        <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity.&#xD;
Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative).&#xD;
This Outcome is only measured for Arm 2 of this study.</description>
        <time_frame>Approximately 1 day post-scan for patient results</time_frame>
        <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of 11C Choline PET Imaging Scans</title>
          <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity.&#xD;
Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative).&#xD;
This Outcome is only measured for Arm 2 of this study.</description>
          <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
          <units>% of correctly identified positives</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="97.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Specificity of 11C Choline PET Imaging Scans</title>
        <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity.&#xD;
Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive).&#xD;
This Outcome is only measured and reported for Arm 2.</description>
        <time_frame>Approximately 1 day post-scan for patient results</time_frame>
        <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity of 11C Choline PET Imaging Scans</title>
          <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity.&#xD;
Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive).&#xD;
This Outcome is only measured and reported for Arm 2.</description>
          <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
          <units>% correctly identified negatives</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans</title>
        <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value.&#xD;
Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive).&#xD;
This Outcome is only measured for Arm 2.</description>
        <time_frame>Approximately 1 day post-scan for patient results</time_frame>
        <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans</title>
          <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value.&#xD;
Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive).&#xD;
This Outcome is only measured for Arm 2.</description>
          <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
          <units>Probability of disease (%)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="76.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans</title>
        <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value.&#xD;
Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative).&#xD;
This Outcome is only measured for Arm 2.</description>
        <time_frame>Approximately 1 day post-scan for patient results</time_frame>
        <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans</title>
          <description>The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value.&#xD;
Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative).&#xD;
This Outcome is only measured for Arm 2.</description>
          <population>Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.</population>
          <units>Probability of being disease-free (%)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="90.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation</title>
        <description>Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.</description>
        <time_frame>Approximately 1 day post-scan for patient results</time_frame>
        <population>This population only includes those Arm 2 participants with positive PET imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation</title>
          <description>Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.</description>
          <population>This population only includes those Arm 2 participants with positive PET imaging.</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="0"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive PET, Negative CT, Negative MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive PET, Positive CT, Negative MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive PET, Negative CT, Positive MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive PET, Positive CT, Positive MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Age at Primary Treatment</title>
        <description>The median age at primary treatment for Arm 2 participants.</description>
        <time_frame>The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only Arm 2 participants' data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median Age at Primary Treatment</title>
          <description>The median age at primary treatment for Arm 2 participants.</description>
          <population>Only Arm 2 participants' data was collected.</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="63" lower_limit="48" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median PSA at Diagnosis of Arm 2 Participants</title>
        <description>The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.</description>
        <time_frame>The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only Arm 2 participants' data was collected. *Note: 4 participants' PSA was not reported.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median PSA at Diagnosis of Arm 2 Participants</title>
          <description>The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.</description>
          <population>Only Arm 2 participants' data was collected. *Note: 4 participants' PSA was not reported.</population>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13.07" lower_limit="1.29" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical T (cT) Stage of Arm 2 Participants</title>
        <description>An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
        <time_frame>The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical T (cT) Stage of Arm 2 Participants</title>
          <description>An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
          <population>Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported.</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="0"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>cT Stage: T1c</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>cT Stage: T2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Primary Biopsy Gleason Score of Arm 2 Participants</title>
        <description>The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.&#xD;
The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.&#xD;
Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).&#xD;
The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.&#xD;
Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.</description>
        <time_frame>The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median Primary Biopsy Gleason Score of Arm 2 Participants</title>
          <description>The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.&#xD;
The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.&#xD;
Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).&#xD;
The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.&#xD;
Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.</description>
          <population>Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7" lower_limit="5" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Treatment Modality of Arm 2 Participants</title>
        <description>An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.&#xD;
Modalities reported below are:&#xD;
Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)</description>
        <time_frame>The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 Participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Treatment Modality of Arm 2 Participants</title>
          <description>An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.&#xD;
Modalities reported below are:&#xD;
Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)</description>
          <population>Only data collected from Arm 2 Participants.</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="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>ADT</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADT + Brachytherapy</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADT + EBRT + Brachytherapy</title>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Brachytherapy</title>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Brachytherapy + EBRT</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cystoprostratectomy</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>EBRT</title>
                  <measurement_list>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>EBRT + ADT</title>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IMRT</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>RP</title>
                  <measurement_list>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants</title>
        <description>The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
        <time_frame>The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants</title>
          <description>The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.&#xD;
T1: PC is too small to be seen on a scan or felt during prostate examination&#xD;
T1a: PC is in &lt; 5% of removed tissue&#xD;
T1b: PC is in &gt; 5% or more of removed tissue&#xD;
T1c: PC is found by biopsy&#xD;
T2: PC is completely inside prostate&#xD;
T2a: PC is in only half of one side of prostate&#xD;
T2b: PC is in more than half of one side of prostate, but not both sides&#xD;
T2c: PC is in both sides but is still inside prostate&#xD;
T3: PC has broken through the capsule of prostate&#xD;
T3a: PC has broken through the capsule of prostate&#xD;
T3b: PC has spread into seminal vesicles&#xD;
T4: PC has spread into other nearby body organs</description>
          <population>Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients.</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="0"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>pT2a</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>pT2c</title>
                  <measurement_list>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>pT3a</title>
                  <measurement_list>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>pT3b</title>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Surgical Margins of Arm 2 Participants</title>
        <description>A census of the primary surgical margins of participants in Arm 2 will reported.&#xD;
The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.&#xD;
Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.</description>
        <time_frame>The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Surgical Margins of Arm 2 Participants</title>
          <description>A census of the primary surgical margins of participants in Arm 2 will reported.&#xD;
The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.&#xD;
Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.</description>
          <population>Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants.</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="0"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Negative Surgical Margins</title>
                  <measurement_list>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive Surgical Margins</title>
                  <measurement_list>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Positive Lymph Node Ratio of Arm 2 Participants</title>
        <description>A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.&#xD;
The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.</description>
        <time_frame>The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Positive Lymph Node Ratio of Arm 2 Participants</title>
          <description>A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.&#xD;
The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.</description>
          <population>Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants.</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="0"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NX</title>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N0</title>
                  <measurement_list>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1</title>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Additional Treatment and Type for Arm 2 Participants</title>
        <description>A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.&#xD;
None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection</description>
        <time_frame>The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Additional Treatment and Type for Arm 2 Participants</title>
          <description>A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.&#xD;
None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection</description>
          <population>only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant.</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="0"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adjuvant RT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilateral Pelvis Lymph Node Dissection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EBRT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lycopene</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Salvage RP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Salvage RT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Salvage RT + ADT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Months to Biochemical Relapse of Arm 2 Participants</title>
        <description>The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.</description>
        <time_frame>The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median Months to Biochemical Relapse of Arm 2 Participants</title>
          <description>The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.</description>
          <population>only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="40" lower_limit="2" upper_limit="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Age of Arm 2 Participant at PET Imaging</title>
        <description>The median age (at time of study) of participants of Arm 2 will be reported in years.</description>
        <time_frame>The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 participants is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median Age of Arm 2 Participant at PET Imaging</title>
          <description>The median age (at time of study) of participants of Arm 2 will be reported in years.</description>
          <population>Only data collected from Arm 2 participants is reported.</population>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="69" lower_limit="50" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median PSA of Arm 2 Participant at PET Imaging</title>
        <description>The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood</description>
        <time_frame>The participants' PSA was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>only data collected for Arm 2 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median PSA of Arm 2 Participant at PET Imaging</title>
          <description>The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood</description>
          <population>only data collected for Arm 2 participants.</population>
          <units>ng/ml of blood</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.58" lower_limit="0.24" upper_limit="107.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median PSA Doubling Time of Arm 2 Participants at PET Imaging</title>
        <description>The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.</description>
        <time_frame>The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median PSA Doubling Time of Arm 2 Participants at PET Imaging</title>
          <description>The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.</description>
          <population>Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.91" lower_limit="0" upper_limit="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median PSA Velocity of Arm 2 Participants at PET Imaging</title>
        <description>The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.</description>
        <time_frame>The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>Median PSA Velocity of Arm 2 Participants at PET Imaging</title>
          <description>The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.</description>
          <population>Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants.</population>
          <units>ng/mL/month</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.09" lower_limit="0" upper_limit="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ADT (Androgen Deprivation Therapy) in Participant at PET Imaging</title>
        <description>An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).</description>
        <time_frame>The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)</time_frame>
        <population>Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
            <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>11C-choline Comparison Study of CT and MR Modalities</title>
            <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
          </group>
        </group_list>
        <measure>
          <title>ADT (Androgen Deprivation Therapy) in Participant at PET Imaging</title>
          <description>An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).</description>
          <population>Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants.</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="0"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No ADT received</title>
                  <measurement_list>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ADT received</title>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were monitored throughout the imaging process during the administration of the imaging agents and immediately thereafter. They were contacted within 1 day after the scan for assessment.</time_frame>
      <desc>Adverse Events were assessed per the standard Adverse Events definition. Patients were contacted by telephone 24 hours post-C11 Choline PET scan for any follow-up concerns and were also told to report any immediate or additional concerns.</desc>
      <group_list>
        <group group_id="E1">
          <title>11C-choline for Staging of Recurrent Prostate Cancer</title>
          <description>The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available.&#xD;
Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.</description>
        </group>
        <group group_id="E2">
          <title>11C-choline Comparison Study of CT and MR Modalities</title>
          <description>11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.&#xD;
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images&#xD;
11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:&#xD;
15 - millicuries (mCi) 11C-choline IV Injection&#xD;
PET images skull base to mid thigh with 3 min per bed position&#xD;
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol&#xD;
Fusion of PET and CT images&#xD;
2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:&#xD;
No IV contrast&#xD;
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs&#xD;
Fusion of coronal and PET images</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Thomas H. Tarter, M.D., Ph.D - Director, Urologic Oncology, Cancer Care Specialists of Illinois</name_or_title>
      <organization>Decatur Memorial Hospital, Decatur, IL</organization>
      <phone>(217) 876-6600</phone>
      <email>ttarter@ccsci.net</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/NCT02260817
org study id: ZM-CCH-40-PTL0114
nct id: NCT02260817
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
This Phase 3 study will target approximately 100 men over age 18 who have a biochemical
      relapse or other evidence of relapse of prostate cancer after primary treatment.

      The purpose of this study is to:

      A. Provide expanded access the drug 11C-choline.

      B. Determine the performance characteristics (sensitivity, specificity, positive predictive
      value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and
      PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in
      patients with biochemical relapse of prostate cancer after primary treatment in a prospective
      manner.

      C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT
      and PET/MRI positive patients through a prospective study.

      D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a
      multivariable analysis of clinical and pathologic data collected prospectively.

      E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline
      PET/MRI and the combination of 11C-choline PET/CT and PET/MRI

      Study Protocol:

        1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.

        2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.

        3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic
           prostate cancer.

        4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with
           biopsy or surgical pathology when possible, or by response to treatment on subsequent
           imaging.

        5. Rates of confirmed metastasis between conventional CT and MRI images will be compared
           with the 11C-choline PET CT and MRI images.

        6. Upon conclusion of each imaging protocol, the referring physician will receive written
           documentation of the results. At this time, the patient will be considered off study and
           no further follow up is required.
1. The first arm of this study serves to provide expanded access to 11C-choline injection
           as currently defined under the reference listed drug label as an investigational drug in
           geographical service areas where 11C-choline is not available. The second arm expands
           access as well but also attempts to determine the more effective imaging modality and
           conditions between PET/CT and PET/MR.

        2. The study will consist of patients who have a biochemical relapse or other evidence of
           relapse after primary treatment. The first arm of the study is open to as many patients
           who elect to participate in the study that are over the age of 18 and have experienced a
           biochemical relapse of prostate cancer after primary treatment. The second arm will
           consist of patients who have been treated with radiation therapy, or androgen
           suppression and radiation therapy who have a PSA > 2 ng/mL higher than the nadir level.
           The nadir level in patients who have been treated with androgen suppression and
           radiation therapy is determined after the serum testosterone level has normalized. This
           study group will also consist of patients who have been treated with radical
           prostatectomy and who have a biochemical relapse defined as a PSA of 0.2 ng/mL confirmed
           at that level or higher on a subsequent PSA test 3 months later. This group may consist
           of men who have other clinical evidence of relapse such as a suspicious bone scan or CT
           scan regardless of PSA kinetics. Patients identified as potential subjects will be
           screened against the eligibility criteria as defined above in Section 5.1.

        3. Informed consent will be obtained from all participants before any study related
           procedures are conducted. Each participant will be informed about the nature of the
           study, its purpose, and possible risks. Informed consent will be documented by using the
           written informed consent document approved by the local IRB at the Decatur Memorial
           Hospital.

        4. At the time of referral, patients will be asked to bring their prior records as it
           pertains to their prostate cancer history. Data collected from outside records, such as
           radiographic studies, previous imaging studies and biopsies will be incorporated into
           the study record.

        5. Abstracted data for the study record will include:

             1. Patient demographics such as age, race, and family history of prostate cancer

             2. Risk factors such as finasteride or dutasteride use, and environmental exposure
                (eg. Agent orange)

             3. Prostate exam results, most recent within last 90 days

             4. PSA test results, most current and past

             5. Past medical and surgical history

             6. Current medications

             7. Allergies

             8. Pathology reports

             9. Imaging reports

            10. Date of diagnosis

            11. Date(s) of biochemical relapse and coordinating PSA results. Once all records have
                been assessed for eligibility, an order for the 11C-choline PET CT scan and MRI
                scan will be requested from the referring physician and patient will be scheduled
                and given the appropriate prep instructions.

        6. Both arms of the study will undergo a 11C-choline PET CT scan and MRI scan. The CT scan
           will be performed with intravenous contrast unless deemed unsafe by lab values. The CT
           and MRI images will be evaluated for evidence of metastatic prostate cancer. The
           11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate
           cancer. Unequivocal evidence of metastasis on both conventional imaging and 11C-choline
           PET will be considered a true positive. Evidence of metastasis on conventional imaging
           or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or
           by response to treatment on subsequent imaging. If confirmation of metastasis is not
           achievable by biopsy or surgical pathology, then confirmation will be achieved with
           11C-choline PET CT and MRI images obtained 3 months after treatment conclusion. Rates of
           confirmed metastasis between conventional CT and MRI images will be compared with the
           11C-choline PET CT and MRI images.

        7. Upon conclusion of each imaging protocol, the referring physician will receive written
           documentation of the results. At this time, the patient will be considered off study and
           no further follow up is required.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evidence of Metastatic Prostate Cancer
time frame: After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.
description: The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study.
True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy.
True Negative: True negatives will consist of negative images.
False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment.
False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.
measure: Sensitivity of 11C Choline PET Imaging Scans
time frame: Approximately 1 day post-scan for patient results
description: The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity.
Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative).
This Outcome is only measured for Arm 2 of this study.
measure: Specificity of 11C Choline PET Imaging Scans
time frame: Approximately 1 day post-scan for patient results
description: The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity.
Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive).
This Outcome is only measured and reported for Arm 2.
measure: Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans
time frame: Approximately 1 day post-scan for patient results
description: The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value.
Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive).
This Outcome is only measured for Arm 2.
measure: Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans
time frame: Approximately 1 day post-scan for patient results
description: The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value.
Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative).
This Outcome is only measured for Arm 2.
measure: Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
time frame: Approximately 1 day post-scan for patient results
description: Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.
measure: Median Age at Primary Treatment
time frame: The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)
description: The median age at primary treatment for Arm 2 participants.
measure: Median PSA at Diagnosis of Arm 2 Participants
time frame: The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)
description: The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.
measure: Clinical T (cT) Stage of Arm 2 Participants
time frame: The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)
description: An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.
T1: PC is too small to be seen on a scan or felt during prostate examination
T1a: PC is in < 5% of removed tissue
T1b: PC is in > 5% or more of removed tissue
T1c: PC is found by biopsy
T2: PC is completely inside prostate
T2a: PC is in only half of one side of prostate
T2b: PC is in more than half of one side of prostate, but not both sides
T2c: PC is in both sides but is still inside prostate
T3: PC has broken through the capsule of prostate
T3a: PC has broken through the capsule of prostate
T3b: PC has spread into seminal vesicles
T4: PC has spread into other nearby body organs
measure: Median Primary Biopsy Gleason Score of Arm 2 Participants
time frame: The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)
description: The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.
The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.
Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).
The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.
Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.
measure: Primary Treatment Modality of Arm 2 Participants
time frame: The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)
description: An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.
Modalities reported below are:
Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)
measure: Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
time frame: The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)
description: The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.
T1: PC is too small to be seen on a scan or felt during prostate examination
T1a: PC is in < 5% of removed tissue
T1b: PC is in > 5% or more of removed tissue
T1c: PC is found by biopsy
T2: PC is completely inside prostate
T2a: PC is in only half of one side of prostate
T2b: PC is in more than half of one side of prostate, but not both sides
T2c: PC is in both sides but is still inside prostate
T3: PC has broken through the capsule of prostate
T3a: PC has broken through the capsule of prostate
T3b: PC has spread into seminal vesicles
T4: PC has spread into other nearby body organs
measure: Primary Surgical Margins of Arm 2 Participants
time frame: The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)
description: A census of the primary surgical margins of participants in Arm 2 will reported.
The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.
Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.
measure: Primary Positive Lymph Node Ratio of Arm 2 Participants
time frame: The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)
description: A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.
The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.
measure: Additional Treatment and Type for Arm 2 Participants
time frame: The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)
description: A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.
None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection
measure: Median Months to Biochemical Relapse of Arm 2 Participants
time frame: The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)
description: The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.
measure: Median Age of Arm 2 Participant at PET Imaging
time frame: The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)
description: The median age (at time of study) of participants of Arm 2 will be reported in years.
measure: Median PSA of Arm 2 Participant at PET Imaging
time frame: The participants' PSA was collected upon study enrollment (approximately 1 week into study)
description: The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood
measure: Median PSA Doubling Time of Arm 2 Participants at PET Imaging
time frame: The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)
description: The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.
measure: Median PSA Velocity of Arm 2 Participants at PET Imaging
time frame: The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)
description: The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.
measure: ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
time frame: The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)
description: An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).
arm group label: Expanded Access for 11C-Choline
arm group type: Experimental
description: The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available.
Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.
arm group label: 11C-Choline Comparison of Modalities
arm group type: Experimental
description: 11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.
Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images
intervention type: Drug
intervention name: 11C-choline Injection
description: Choline C11 Injection for PET/CT Imaging Protocol:
15 - millicuries (mCi) 11C-choline IV Injection
PET images skull base to mid thigh with 3 min per bed position
Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
Fusion of PET and CT images
Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
No IV contrast
High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
Fusion of coronal and PET images
arm group label: 11C-Choline Comparison of Modalities
arm group label: Expanded Access for 11C-Choline
other name: CCH Injection, C11 Choline Injection
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas H Tarter, M.D, Ph.D
role: Principal Investigator
affiliation: Decatur Memorial Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Choline
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 