Gallium-68 PSMA-11 PET/CT for the Diagnosis of Biochemically Recurrent Prostate Cancer

Inclusion Criteria

• Histopathological proven prostate adenocarcinoma
• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam and/or brachytherapy) or prostate cancer ablation * Post radical prostatectomy (RP) – with or without radiation ** PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP ** > 3 months post-surgery * Post-radiation therapy – American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition * May or may not be castrate resistant (list prior therapies, i.e. androgen deprivation therapies) * Post-prostate cancer tissue ablation ** In patients post-ablation for primary prostate cancer treatment, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after ablation ** > 3 months post-prostate bed ablation ** In patients with intact prostate, per ASTRO-Phoenix consensus definition
• Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
• CT as part of the PET study or performed within 30 days of PSMA PET
• Ability to understand a written informed consent document, and the willingness to sign it
• Total testosterone test measured within 30 days of PSMA PET

Exclusion Criteria

• Undergoing (or within 4 months) investigational therapy for prostate cancer
• Other ongoing (or within 4 months) treatments for prostate cancer including radiation therapy or chemotherapy
• Unable to lie flat, still or tolerate a PET scan
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized
• Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)
• Absence of PSA and total testosterone tests within 30 days