Abstract
PURPOSE: This study aimed to develop and validate a predictive model for the assessment of clinically significant prostate cancer (csPCa) in men, prior to prostate biopsies, based on bi-parametric magnetic resonance imaging (bpMRI) and clinical parameters. MATERIALS AND METHODS: We retrospectively analyzed 300 men with clinical suspicion of prostate cancer (prostate-specific antigen [PSA] ≥ 4.0 ng/mL and/or abnormal findings in a digital rectal examination), who underwent bpMRI-ultrasound fusion transperineal targeted and systematic biopsies in the same session, at a Korean university hospital. Predictive models, based on Prostate Imaging Reporting and Data Systems scores of bpMRI and clinical parameters, were developed to detect csPCa (intermediate/high grade [Gleason score ≥ 3+4]) and compared by analyzing the areas under the curves and decision curves. RESULTS: A predictive model defined by the combination of bpMRI and clinical parameters (age, PSA density) showed high discriminatory power (area under the curve, 0.861) and resulted in a significant net benefit on decision curve analysis. Applying a probability threshold of 7.5%, 21.6% of men could avoid unnecessary prostate biopsy, while only 1.0% of significant prostate cancers were missed. CONCLUSION: This predictive model provided a reliable and measurable means of risk stratification of csPCa, with high discriminatory power and great net benefit. It could be a useful tool for clinical decision-making prior to prostate biopsies.