Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

• Status: Completed
• Trial end date: 2017-09-21
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Edetic Acid

Criteria

Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma.

• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,

• Confirmatory persistent PSA greater than 0.2 ng/mL

• Post-radiation therapy -ASTRO-Phoenix consensus definition

• Nadir + greater than or equal to 2 ng/mL rise in PSA

• Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).

• Age > 18.

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Investigational therapy for prostate cancer.

• 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 and superficial bladder cancer.

• 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).