Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis.

Purpose : Non-White patients are poorly represented in prostate cancer trials. MRI PI-RADS scoring was developed in primarily White populations, but prostate cancer differs in non-White men. We aimed to explore differences in PI-RADS calibration for Asian and Black men. Materials and Methods: This is a secondary analysis of PREVENT, a multi-institutional study of infection rates for transrectal vs. transperineal biopsy. We compared cancer detection for self-identifying Asian and Black men. We compared detection rates on a per-person basis, stratified by index PI-RADS lesion, to White men, using Fisher’s exact and logistic regression. Results: Of 665/752 trial patients with PI-RADS 3-5 lesions, 88 (13%) were Black and 36 (6%) were Asian. Black men were younger at diagnosis with increased rates of overall (70% vs. 43%%, P =0.004) and clinically significant prostate cancer (60% vs. 27%, P =0.003) and Asian men had decreased rates of overall (0% vs. 47%, P =0.004) and clinically significant prostate cancer (0% vs. 27%, P =0.003) in PI-RADS 3 lesions compared to White men. On multivariable regression, Black men with PI-RADS 3/4 lesions had higher odds of overall (OR 1.17, P =0.009) and clinically significant prostate cancer (OR 1.20, P =0.004) and Asian men had lower odds of overall (OR 0.79, P =0.01) but not clinically significant prostate cancer (OR 0.94, P =0.5). Conclusions: Black men with PI-RADS 3/4 lesions had 20% higher odds of clinically significant prostate cancer than White men while all PI-RADS 3 lesions in Asian men were negative. These findings suggest PI-RADS may require differential interpretation when assessing prostate cancer risk in non-White men. Source of Funding: Supported by the NCI (5R01CA241758-05). Trial Registration: Registered at ClinicalTrials.gov (NCT04843566, https://clinicaltrials.gov/study/NCT04843566).