Assessment of the Diagnostic Accuracy of Biparametric Magnetic Resonance Imaging for Prostate Cancer in Biopsy-Naive Men: The Biparametric MRI for Detection of Prostate Cancer (BIDOC) Study.

Importance: Multiparametric magnetic resonance imaging (MRI) enhances detection and risk stratification for significant prostate cancer but is time-consuming (approximately 40 minutes) and expensive. Rapid and simpler (approximately 15-minute) biparametric MRI (bpMRI) using fewer scan sequences could be implemented as a prostate MRI triage test on a larger scale before performing biopsies. Objectives: To assess the diagnostic accuracy and negative predictive value (NPV) of a novel bpMRI method in biopsy-naive men in detecting and ruling out significant prostate cancer in confirmatory biopsies. Design, Setting, and Participants: A single-institutional, paired, prospective cohort study of biopsy-naive men with clinical suspicion of prostate cancer from November 1, 2015, to June 15, 2017. Interventions: All patients underwent bpMRI (T2-weighted and diffusion-weighted imaging) followed by standard transrectal ultrasound-guided biopsies (all men) and targeted biopsies of men with suspicious bpMRI findings. Main Outcomes and Measures: Suspicion grades of bpMRI, biopsy results, and NPV of bpMRI were evaluated for detection of or ruling out significant prostate cancer (Gleason score ≥4 + 3 or maximum cancerous core length >50% for Gleason score 3 + 4). We compared the diagnostic performance of standard biopsies in all men vs standard plus targeted (combined) biopsies restricted to men with suspicious bpMRI findings. The reference standard was combined biopsy results from all men. Results: A total of 1020 men were enrolled, with a median age of 67 years (interquartile range, 61-71 years) and a median prostate-specific antigen level of 8.0 ng/mL (interquartile range, 5.7-13.0 ng/mL). Combined biopsies detected any and significant prostate cancer in 655 of 1020 men (64%) and 404 of 1020 men (40%), respectively. Restricting combined biopsies to men with suspicious bpMRI findings meant 305 of 1020 men (30%) with low-suspicious bpMRIs could avoid prostate biopsies (biopsy in 715 men with suspicious bpMRIs vs all 1020 men who required standard biopsies [70%]; P < .001). Significant prostate cancer diagnoses were improved by 11% (396 vs 351 men; P < .001), and insignificant prostate cancer diagnoses were reduced by 40% (173 vs 288 men; P < .001) compared with our current diagnostic standard, standard biopsies alone in all men. The NPV of bpMRI findings in ruling out significant prostate cancer was 97% (95% CI, 95%-99%). Conclusions and Relevance: Low-suspicion bpMRI has a high NPV in ruling out significant prostate cancer in biopsy-naive men. Using a simple and rapid bpMRI method as a triage test seems to improve risk stratification and may be used to exclude aggressive disease and avoid unnecessary biopsies with its inherent risks. Future studies are needed to fully explore its role in clinical prostate cancer management.