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.
Cancers. 2025 Jan 31*** epublish ***
Nahuel Paesano, Violeta Catalá, Larisa Tcholakian, Xavier Alomar, Miguel Ángel Barranco, Jonathan Hernández-Mancera, Berta Miró, Enrique Trilla, Juan Morote
Department of Surgery, Universitat Autònoma de Barcelona, 08193 Bellaterra, Spain., Clínica Creu Blanca, 08034 Barcelona, Spain., Fundació Puigvert, 08025 Barcelona, Spain., Statistics Unit, Vall d'Hebron Research Institute, 08035 Barcelona, Spain.