Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

• Status: Completed
• Trial end date: 2019-12-31
• 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 high risk disease prior to prostatectomy.

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

Details

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

Criteria

Inclusion Criteria:

• Biopsy proven prostate adenocarcinoma.

• Planned prostatectomy with lymph node dissection.

• Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).

• Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.

• 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:

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.

• Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.

• Including focal ablation techniques (HiFu).

• Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.