Negative Predictive Value of a Prostate MRI in Black Men: Implications for Biopsy Decision-Making.

Purpose: Prostate Imaging Reporting and Data System (PIRADS) v2.1 scoring with multiparametric (mp) MRI has a pooled 90% negative predictive value (NPV). PSA density (PSAD) ≤ 0.15 ng/mL/cm³ has been shown to enhance mpMRI's NPV in non-Black men. Populations with higher disease prevalence are known to have lower NPVs. Given that Black men have higher prostate cancer prevalence, we evaluate sensitivity and NPV of mpMRI in Black vs non-Black men to assess possible mpMRI performance differences. As an exploratory objective, we investigate PSAD thresholds providing ≥ 90% sensitivity in Black men.

Materials and methods: We prospectively recruited Black and non-Black men referred to outpatient urology clinics for abnormal PSA or prostate examination in 3 similar biomarker validation studies from 2017 to 2023 before MRI-informed diagnostic prostate biopsy. We combined the research cohorts with a retrospective clinical cohort of clinically similar Black and non-Black men from 1 academic institution who also underwent mpMRIs and MRI-informed biopsies. MRIs were scored using PIRADS version 2.0 or 2.1.

Results: Our analysis included 286 Black men and 965 non-Black men with PSA ≤ 15.0 ng/mL. PIRADS < 3 had an NPV of 77.1% vs 87.6% and a sensitivity of 90.7% vs 96.3% for Gleason grade group 2 to 5 prostate cancer in Black vs non-Black men, respectively (both P < .05). Using PSAD ≥ 0.09 for Black men with PIRADS 1 to 2 lesions increased sensitivity to 92.9%.

Conclusions: PIRADS < 3 has a lower NPV and sensitivity in Black men. For negative prostate MRIs, PSAD ≥ 0.09 may be a better threshold for safe biopsy deferral in Black men to maintain a ≥ 90% sensitivity.