Digital rectal exam vs. electronic "digitized" prostate exam.

BACKGROUND: The current era of multiparametric prostate MRI (mpMRI) and ultrasound (US)/ MRI fusion has improved early detection of clinically significant prostate cancer (csPCa) while decreasing the number of unnecessary biopsies. Hence, this study aims to define the diagnostic value of pre-biopsy digital rectal examination (DRE) for screening and detection of csPCa, when there is access to mpMRI and prostate-specific antigen (PSA). METHODS: This retrospective, single-center study involved 3379 consecutive patients biopsied between 2012 and 2023 using both MRI/US-targeted fusion and systematic approaches. Biopsies were indicated because of elevated PSA levels and/or presence of cancer suspicious lesions on MRI. All patients underwent DRE and mpMRI prior to biopsy. csPCa was defined as Gleason grade group ≥2. Diagnostic performance of DRE for csPCa was compared to PSA and PSA density (PSAD) using receiver operating characteristic curves. RESULTS: Two thousand one hundred eighty-eight (65%) patients were diagnosed with PCa and 1498 (44%) patients with csPCa. DRE was positive in 410/3379 (12%) patients. 261/410 (64%) DRE positive patients had confirmed csPCa, of which 160/261 (61%) were located in immediate proximity to the rectum. mpMRI was positive for focal lesion(s) in 1494/1498 (100%) csPCa patients. For csPCa detection, DRE had a sensitivity of 0.17, specificity of 0.92, a positive predictive value of 0.63 and a negative predictive value of 0.59. Compared to DRE (AUC 0.55 [CI95% 0.54, 0.56]), PSA (AUC 0.63 [CI95% 0.61, 0.64]) and PSAD (AUC 0.73 [CI95% 0.71, 0.74]) showed better csPCa prediction performance (both p < 0.001). CONCLUSIONS: Pre-biopsy DRE was found to add little to no diagnostic value for the routine diagnostic workflow in a constrained setting when PSA and mpMRI are initial screening tools for patients with suspected csPCa.