Risk-based MRI-directed diagnostic pathway outperforms non-risk-based pathways in suspected prostate cancer biopsy-naïve men: a large cohort validation study.

• Our study recognizes the added value of prostate MRI and MR-targeted biopsies in order to propose clinical diagnostic pathways for prostate cancer, towards maximizing the potential avoidance of unnecessary biopsies, while maintaining optimal detection rate of clinically significant prostate cancer. • The risk-based MRI-directed pathway incorporates risk factors such as PSA density, digital rectal examination, and family history to further refine the initial stratification of patients based on PI-RADS scores. • In this study, the risk-based pathway had the most optimal performance in terms of combination of outcomes, with the highest rate of biopsy avoidance (19.2%), while keeping a high detection rate of clinically significant prostate cancer (51.7%), when compared to the reference standard (52.9%).