Abstract C014: Lower negative predictive value of prostate MRI in Black men

Abstract Introduction: PIRADS scoring with multiparametric-MRI (MRI) has a pooled 90% negative predictive value (NPV) allowing men to defer biopsy while enhancing Gleason Grade group 2-5 (GG2-5) prostate cancer (PCa) detection. PSA density (PSAD) ≥0.15ng/ml/cm3 has been shown to enhance NPV of the prostate MRI in non-Black men. We assessed the performance of the prostate MRI in Black vs. non-Black men by evaluating sensitivity and NPV, and identified a PSAD threshold providing ≥90% NPV in Black men. Methods: We prospectively recruited Black and non-Black men referred to outpatient urology clinics for abnormal PSA or prostate exam in three similar biomarker validation studies from 2017–23 before MRI-informed diagnostic transrectal or transperineal prostate biopsy. We combined this research cohort with a retrospective clinical cohort of clinically similar Black and non-Black men from one academic institution who also underwent prostate MRIs and MRI-informed biopsies for elevated PSA. Trained radiologists used PIRADS version 2.0 or 2.1 for scoring. Results: Following the combination of the research and clinical cohorts, 286 Black men and 965 non-Black men with PSA<15.0ng/ml were included in the analysis. PIRADS ≥3 had an NPV of 77.1% versus 87.6% and a sensitivity of 90.7% vs. 96.3% for GG2-5 PCa in Black versus non-Black men, respectively (both p<0.05). Using PSAD ≥0.09 for Black men with PIRADS 1-2 lesions increased sensitivity to 92.9%. For PIRADS 1-2, GG2-5 PCa frequency was 5.3% higher in Black versus non-Black men with PSAD<0.15, and 11.0% higher in Black versus non-Black men with PSAD≥0.15. For PIRADS=3, GG2-5 PCa frequency was 9.1% higher in Black men with PSAD<0.15 and 27.9% higher for PSAD≥0.15. For PIRADS=4, GG2-5 PCa frequency was 15.9% higher in Black men with PSAD<0.15, and 9.5% higher for PSAD≥0.15. Conclusion: The PIRADS ≥3 threshold has a lower NPV and sensitivity in Black men. A negative prostate MRI requires a PSAD ≥0.09 threshold for safe biopsy deferral in Black men to maintain a sensitivity ≥90%. Citation Format: Sarah Sandlow, Samuel Carbunaru MD, Zequn Sun PhD, Bernice Ofori MPH, Courtney M. P. Hollowell MD, Patricia Vidal MD, Eric Li MD, Edward M. Schaeffer MD, PhD, Peter Gann MD, ScD, Ashley Ross MD, PhD, Shilajit Kundu MD, Adam B. Murphy MD, MBA, MSCI. Lower negative predictive value of prostate MRI in Black men [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr C014.