869da46b90e22c0e907106fd6e5ebf6c cancers-18-01810.pdf e7b1b1934dcaf7a61227f1fecb031fd9fe662d32 cancers-18-01810.pdf c0e20b54ea8c8cff8cfa81b53832606e405d2ad5def153568ab7d0399c27ea9e cancers-18-01810.pdf Title: External Validation and Clinical Impact of the Barcelona Predictive Models for Detecting Significant Prostate Cancer in Prostate Biopsies in an Ibero-American Population Subject: 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. Keywords: prostate cancer; screening; predictive models Author: Nahuel Paesano, Juan Camean, Maximiliano Ringa, Maximiliano López-Silva, Guido Koren, Tomás Eduardo Olmedo, Joaquín Ignacio Gurovich, Edgar Iván Bravo-Castro, Violeta Catalá, Pablo Contreras, Juan Justo-Quintas, José Miguel Pérez-Ruiz, Silvia García-Barreras, Berta Miró, Lucas Regis, Olga Méndez, Enrique Trilla and Juan Morote Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25; modified using OpenPDF 1.4.2 CreationDate: Mon Jun 1 09:12:31 2026 CEST ModDate: Mon Jun 1 09:48:09 2026 CEST Custom Metadata: yes Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 16 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 4717481 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- UPIPOY+URWPalladioL-Bold Type 1 Custom yes yes yes 128 0 MIKRSI+VnURWPalladioL Type 1 Custom yes yes yes 129 0 IQMRXI+URWPalladioL-Roma Type 1 Custom yes yes yes 130 0 MWUQSP+URWPalladioL-Ital Type 1 Custom yes yes yes 131 0 IKKWKP+CMSY10 Type 1 Builtin yes yes yes 132 0 WBVKDJ+URWPalladioL-BoldItal Type 1 Custom yes yes yes 251 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-07-09 03:57:16 CEST RepresentationInformation: cancers-18-01810.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-07-08 11:44:00 CEST Size: 4717481 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 438 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: ViewerPreferences: HideToolbar: false HideMenubar: false HideWindowUI: false FitWindow: true CenterWindow: false DisplayDocTitle: false NonFullScreenPageMode: UseNone Direction: L2R ViewArea: CropBox ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Item: Title: Materials and Methods Children: Item: Title: Design, Setting, and Participants Item: Title: PCa Suspicion and Diagnostic Procedure of csPCa Item: Title: Predictive Variables Used in BCN-PMs and Individual csPCa Risk Estimation Item: Title: Statistical Analysis Item: Title: Results Children: Item: Title: Characteristics of Validation Cohort Item: Title: Relationship Between PI-RADS Score and csPCa Detection Item: Title: Analysis of Heterogeneity Among Participant Centers Item: Title: Calibration of BCN-PM 1 and 2 Item: Title: Discrimination Ability of BCN-PM 1 and 2 for csPCa Item: Title: Net Benefit of BCN-PM1 and 2 over Biopsy-All and Biopsy-None Strategies Item: Title: Clinical Utility of BCN-PM 1 and 2 Item: Title: Clinical Usefulness of the BCN Risk-Stratified Pathway Item: Title: Behavior of BCN-PM 2 According to PI-RADS Category Item: Title: Behavior of BCN-PM 1 and 2 According to the Participating Center Item: Title: Discussion Item: Title: Conclusions Item: Title: References Info: Title: External Validation and Clinical Impact of the Barcelona Predictive Models for Detecting Significant Prostate Cancer in Prostate Biopsies in an Ibero-American Population Author: Nahuel Paesano, Juan Camean, Maximiliano Ringa, Maximiliano López-Silva, Guido Koren, Tomás Eduardo Olmedo, Joaquín Ignacio Gurovich, Edgar Iván Bravo-Castro, Violeta Catalá, Pablo Contreras, Juan Justo-Quintas, José Miguel Pérez-Ruiz, Silvia García-Barreras, Berta Miró, Lucas Regis, Olga Méndez, Enrique Trilla and Juan Morote Subject: 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. 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