316 Background: Prostate cancer is the second most common cancer in men and is disproportionately prevalent among African American patients. Several commercially available genomic biomarkers exist to assess the risk of prostate cancer in individual patients; however, studies examining their utility in African American men, especially in combination with prostate MRI, are lacking. This study aimed to evaluate the combined diagnostic and predictive value of pre-biopsy MRI and the ExoDx Prostate (EPI) test for detecting clinically significant prostate cancer (csPCa), defined as Gleason Grade Group 2 or higher, in African American men. Methods: We performed a retrospective analysis of patients who had EPI scores, prostate MRI, and subsequent prostate biopsy at the George Washington Medical Faculty Associates Department of Urology between October 2019 and May 2025, supplemented with clinical data extracted from the Epic EHR. EPI (classified as +EPI ≥ 15.6 and –EPI < 15.6) and MRI data were analyzed across PI-RADS categories (2–5) to assess diagnostic performance metrics, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: A total of 156 patients were included in the analysis. 50 patients were found to have csPCa on prostate biopsy, including 17 (34%) AA patients and 33 (66%) non-AA patients. In the overall cohort, a positive EPI score was associated with a 36.2% risk of csPCa. For all men, AA men, and non-AA men, the risk of csPCa with +EPI and PIRADS 4/5 lesions was 58.1%, 85.7%, and 50%, respectively (AA vs non-AA men p = 0.038). For all men, AA men, and non-AA men, the risk of csPCa with +EPI and PIRADS 3 lesions was 19.3%, 25%, and 17.1%, respectively. For all men, regardless of subgroup, the NPV of -EPI in PIRADS 2/3 lesions was 100%. Conclusions: A positive EPI score significantly increased the risk of csPCa among AA men compared to non-AA men with PIRADS 4/5 lesions. For all subjects with PIRADS 2/3 lesions, a negative EPI had 100% NPV, and may be used as a tool to adjudicate cancer risk in men with equivocal or negative MRIs. These findings support the potential value of the integration of EPI + MRI as a complementary pre-biopsy strategy to enhance risk stratification, equity, and precision in prostate cancer diagnostics. Further validation in larger, prospective, multi-institutional studies is warranted. Baseline demographic and clinical characteristics. Overall (n = 156) AA (n = 46) non-AA (n = 110) Age (avg) 67.4 66.7 67.7 PSA (avg) 6.95 7.75 6.61 PIRADS 2 18 (11.5%) 9 (16.6%) 9 (8.2%) PIRADS 3 67 (42.9%) 20 (43.5%) 47 (42.7%) PIRADS 4/5 71 (45.5%) 17 (37.0%) 54 (49.1%) +EPI ≥ 15.6 130 (83.3%) 36 (78.3%) 94 (85.5%) -EPI < 15.6 26 (16.7%) 10 (21.7%) 16 (14.5%) GG1 36 (23.1%) 8 (17.4%) 28 (25.5%) csPCa (≥ GG2) 50 (32.1%) 17 (37.0%) 33 (30.0%) Negative Biopsy 70 (44.9%) 21 (45.7%) 49 (44.5%)
Turner et al. (Sun,) studied this question.