Gallium Ga 68-labeled PSMA-11 PET/CT in Diagnosing Patients with Biochemical Recurrent Prostate Cancer

Inclusion Criteria

• Pathologically proven prostate adenocarcinoma
• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association [AUA] recommendation for biochemical recurrence) * If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society for Radiation Oncology [ASTRO] recommendation for biochemical recurrence)
• Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an investigational new drug [IND] for initial efficacy investigations)
• No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion)
• Karnofsky performance status (KPS) ≥ 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2)
• Ability to understand and willingness to provide informed consent

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 active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements