Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

• Status: Completed
• Trial end date: 2020-09-01
• 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 its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

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

Details

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

Criteria

Inclusion Criteria

• Histopathologically proven prostate adenocarcinoma.

• Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy

• PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.

• Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

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

• Karnofsky performance status of > 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

• Unable to lie flat, still or tolerate a PET scan.

• Concomitant investigational therapy.

• Patient undergoing active treatment for non-prostate malignancy, 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).