Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study

Inclusion Criteria:

1. Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with
curative intent (surgery and radiation therapy are most common treatments but other
treatments are also eligible).

2. Biochemical recurrence defined as any of the following:

- PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with
surgery.

- PSA ≥ 2.0 ng/mL above the post therapy nadir for patients treated with radiation
therapy, brachytherapy or cryotherapy.

- PSA ≥ 2.0 ng/ml above the most recent therapy nadir for patients who have
received additional treatment in the recurrent setting.

3. Patient must have undergone standard-of-care restaging that does not clearly identify
site(s) of active disease. Standard staging examinations may include one or more of
the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy or
F-18 sodium fluoride PET), OR In-111 capromab pendetide scintigraphy.

4. Age > 18 years.

5. Patient must be able to tolerate PET/MRI or PET/CT imaging

6. Patient must be able to understand and willing to sign a written informed consent
document.

7. Patient must be able to understand and willing to sign an Advance Beneficiary Notice
(ABN) (Medicare patient) or a Notice of Non-coverage (NNC) from (non-Medicare
patient) that addresses the potential cost to the patient of C-11 choline PET/CT or
PET/MRI.

Exclusion Criteria:

1. For patients planned to have PET/MRI:

- Patient must not have claustrophobia or any other contraindication to MRI as
evaluated by a standardized MRI safety questionnaire.

- If applicable, patient must not have renal insufficiency (estimated glomerular
filtration rate < 30 mL/min/1.73 m2 based on measurement within the past 60
days) or be undergoing dialysis as these conditions preclude safe administration
of MRI contrast agents. NOTE: At the discretion of principal investigator, a
subject may be allowed to enroll/continue on study and undergo imaging without
the administration of contrast in the event of renal insufficiency.

- If applicable, patient must not have a known prior reaction to gadolinium based
MRI contrast agents.

2. For patients planned to have PET/CT:

- Patient must not have claustrophobia that would preclude PET/CT imaging or other
contraindications to CT imaging.