Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer

Inclusion Criteria:

• Ability to understand and willingness to provide informed consent.

• Pathologically proven prostate adenocarcinoma.

• Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).

• If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weekspost-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.

• If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mLrise above the lowest PSA value ('nadir').

• A PSA level result within the last 2 months meeting criteria above.

• Not receiving any other investigational agents (i.e., unlabeled drugs or drugs underan IND for initial efficacy investigations).

• No other malignancy within the past 2 years (skin basal cell or cutaneoussuperficial squamous cell carcinoma or superficial bladder cancer are exempt fromthis criterion).

• Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2)within the last 3 months.

Exclusion Criteria:

• Cannot receive furosemide.

• History of Stevens-Johnson syndrome.

• History or diagnosis of Paget's disease.

• Malignancy other than current disease under study.

• Allergy to sulfa or sulfa-containing medications.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.