External Validation and Clinical Impact of the Barcelona Predictive Models for Detecting Significant Prostate Cancer in Prostate Biopsies in an Ibero-American Population.

Objectives: To externally validate the Barcelona Predictive Models (BCN-PM 1 and 2) for detecting csPCa in an Ibero-American population. BCN-PM 1 was designed to reduce magnetic resonance imaging (MRI) use, whereas BCN-PM 2 aims to decrease unnecessary prostate biopsies. Methods: This prospective, multicenter study included 661 men with suspected PCa recruited in 2025 across three Ibero-American centers. All participants underwent MRI followed by targeted biopsies of lesions with the Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3, along with systematic biopsy. When PI-RADS lesions were <3, only systematic biopsies were performed. CsPCa was defined as International Society of Urological Pathology Grade Group ≥ 2. BCN-PM 1 incorporates age (years), family history of PCa (no vs. yes), prior negative prostate biopsy (no vs. yes), digital rectal examination (DRE: normal vs. suspicious), and prostate volume-derived estimation by DRE (small, median, or large). BCN-PM 2 includes age, family history of PCa, prior negative prostate biopsy, prostate volume measured by MRI (mL), and PI-RADS score (1-5). Results: The rate of csPCa detection was 53.7%. Both models demonstrated good calibration with strong agreement between predicted probabilities and observed csPCa rates. BCN-PM 1 closely followed the reference line, with minor deviations at higher predicted probabilities, whereas BCN-PM 2 showed modest departures at the extremes of risk. The area under the curve was 0.740 (95% CI 0.702-0.777) for BCN-PM 1 and 0.803 (95% CI 0.769-0.836) for BCN-PM 2 (p < 0.001). Decision curve analysis demonstrated a net benefit for both models compared with strategies of biopsy in all or no men. BCN-PM 2 showed greater net benefit than BCN-PM 1. At 95% sensitivity, BCN-PM 1 reduced MRI requests by 10.6%, while BCN-PM 2 avoided 19.4% of unnecessary biopsies. The sequential use of BCN-PM 1 and 2 resulted in a 10.6% reduction in MRI exams and a 23.1% reduction in biopsies, at the cost of missing 8.4% of csPCa cases. The performance of the biopsy improved from 53.7% to 64.0% (p < 0.001). Conclusions: BCN-PM1 and BCN-PM 2 were successfully validated in an Ibero-American population.