Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway: Results from a Randomized Prospective Study in Biopsy-naive Patients with Suspected Prostate Cancer

Background: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa). Objective: To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa. Design, setting, and participants: Between November 2014 and April 2016, 212 biopsy-naive patients with suspected PCa (prostate specific antigen level <= 15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n = 107) or a standard biopsy (SB) group (arm B, n = 105). Intervention: In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n = 81). The remaining patients in arm A (n = 26) with negative mpMRI results and patients in arm B underwent 12-core SB. Outcomes measurements and statistical analysis: The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB. Results and limitations: The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p = 0.002) and csPCa (43.9% vs 18.1%, respectively; p < 0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p < 0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p < 0.001). The reproducibility of the study could have been affected by the single-center nature. Conclusions: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa. Patient summary: In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway. (C) 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.