Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
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.
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