18F-DCFPyL PSMA PET/MRI improves detection of clinically significant prostate cancer in men on active surveillance: Results from a Phase II trial

Motivation: High interobserver variability and low-to-moderate sensitivity and specificity for detecting clinically significant prostate cancer (PC) limit the utility multiparametric MRI (mpMRI) in men with PC on active surveillance (AS). Goal(s): To determine the diagnostic accuracy of 18F-DCFPyL PSMA-PET/MRI compared to mpMRI in men with PC on AS. Approach: Prospective diagnostic trial of 100 men with PC on AS. PI-RADS ≥3 and Likert ≥3 lesions, identified by experienced, blinded radiologists and nuclear medicine physicians, respectively, were targeted for PSMA PET/MRI-US fusion biopsy by an experienced urologic oncologist. Results: PSMA PET/MRI improves detection of csPC in men on AS while maintaining high negative predictive value. Impact: Imaging and clinical predictive models that include PSMA PET/MRI may identify low and intermediate-risk men who could potentially avoid prostate biopsy and coincident morbidity, as well as increase the detection rates of csPC missed by MRI-biopsy alone.