PSMA PET Scan and mpMRI for Prostate Cancer Detection

Prostate Cancer Diagnosis Clinical Trial

Official title: Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed. ;

Related Conditions & MeSH terms

• Prostate Cancer Diagnosis
• Prostatic Neoplasms

• NCT number: NCT05820724
• Study type: Interventional
• Source: VA Greater Los Angeles Healthcare System
• Contact: William Aronson, MD
• Phone: 310-268-3446
• Email: william.aronson@va.gov
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Completion date: May 1, 2026