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

Completed · Phase 2/Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02919111

Run by

University of California, San Francisco

People needed

299

Starts

2016-09-23

Expected to finish

2019-12-31

Last updated by the study team

2020-12-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.