Validation of the Barcelona Magnetic Resonance Imaging Predictive Model for Significant Prostate Cancer Detection in Men Undergoing Mapping per 0.5 Mm-Core Targeted Biopsies of Suspicious Lesions and Perilesional Areas

The validation of predictive models is essential for informing clinical decisions, particularly in new individual populations or as diagnostic methods advance. This study evaluates the performance of the Barcelona-MRI predictive model (BCN-MRI PM) for identifying significant prostate cancer (sPCa) within the context of an advanced prostate biopsy protocol. In a cohort of 457 men suspected of having PCa, the model demonstrated high accuracy and clinical applicability, reducing unnece-ssary biopsies by 24.9% while maintaining a 95% detection rate for sPCa. These results validate the efficacy of the BCN-MRI PM and support its readiness for clinical implementation in this diagnostic framework. Background/Objectives: Validation of predictive models (PMs) is crucial to be implemented in new populations or when advances in diagnostic approaches occurred. The aim of this study is to validate the BCN-MRI PM for sPCa when a highly effective prostate biopsy protocol is used. Methods: A prospective cohort of 457 men suspected of having PCa, for whom MRI results were reported with the Prostate Imaging-Reporting and Data System (PI-RADS) v 2.1, underwent a per 0.5 mm-core mapping targeted biopsy of suspicious lesions and perilesional areas, followed by a 12-core-systematic biopsy. These procedures took place between 1 February 2022, and 29 February 2024, at a reference center for prostate biopsy. The individual likelihood of sPCa was assessed through the BCN-MRI risk calculator. Results: The overall sPCa detection rate was 58.3%. The calibration curve of the BCN-MRI PM showed an appropriate accuracy between expected and observed probabilities with a discrimination ability for sPCa yielding an area under the curve (AUC) of 0.862 (95% CI 0.828-0.896) comparable to the AUC of 0.858 (95% CI 0.833-0.883) observed in the development cohort. The application of the BCN-MRI PM provided a net benefit over performing biopsies on all men, avoiding 24.9% of prostate biopsies at 95% sensitivity for sPCa, compared to the 23.7% reduction observed in the development cohort. Conclusions: We conclude that the BCN-MRI PM is ready to be implemented when this biopsy protocol is employed.