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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. ;


Study Design


Related Conditions & MeSH terms


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

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