PSMA PET Scan and mpMRI for Prostate Cancer Detection

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.

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

Details

• Lead Sponsor: VA Greater Los Angeles Healthcare System
• Collaborator: Lantheus Medical Imaging

Criteria

Inclusion Criteria:

• Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy

• Prostate mpMRI completed within 9 months prior to enrollment

• Patient capable of providing written informed consent

• Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT

Exclusion Criteria:

• Less than 18 years-old at the time of radiotracer administration

• Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.

• Creatinine clearance exceeding institutional requirements for prostate mpMRI