Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 11C-choline Injection
Intervention 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
Intervention MeSH terms: Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; 11C Choline; PET Imaging

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. For biochemical relapse after primary treatment

               1. PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on
                  a subsequent test 3 months later

               2. PSA increase >2 ng/ml from nadir following radiation therapy

               3. PSA increase >2 ng/ml from nadir following radiation therapy plus androgen
                  deprivation therapy with nadir defined with normalized testosterone level

               4. Two consecutive PSA increases from nadir level after androgen blockade or
                  androgen suppression therapy

          2. Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within
             90 days of planned scan

               1. if GFR is > or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast

               2. if GFR is < 60 mL/sec/1.73m2, PET/CT will be completed without contrast

               3. if Creatinine is > than 1.7 mg, Radiology will follow ACR recommendations as
                  outlined in department policy.

          3. No known allergy to iodinated radiologic contrast media

          4. Able to have MRI based on screening evaluation. If patient is found to be MRI
             incompatible, the 11C-choline PET/MRI portion of the study will not be completed.
             Please see the provided contact numbers for further options.

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

        Exclusion Criteria:

          1. ECOG Performance Status > 2.

          2. Concurrent malignancy, i.e. colon cancer.

          3. Treatment for another malignancy except superficial skin cancer within 5 years