PURPOSE: Magnetic resonance imaging (MRI) is a promising tool for risk assessment, potentially reducing the burden of unnecessary prostate biopsies. Risk prediction models that incorporate MRI data have gained attention, but their external validation and comparison are essential for guiding clinical practice. The aim is to externally validate and compare risk prediction models for the diagnosis of clinically significant prostate cancer (csPCa). METHODS: A cohort of 4606 patients across fifteen European tertiary referral centers were identified from a prospective maintained database between January 2016 and April 2023. Transrectal or transperineal image-fusion MRI-targeted and systematic biopsies for PI-RADS score of ≥ 3 or ≥ 2 depending on patient characteristics and physician preferences. Probabilities for csPCa, defined as International Society of Urological Pathology (ISUP) grade ≥ 2, were calculated for each patients using eight models. Performance was characterized by area under the receiver operating characteristic curve (AUC), calibration, and net benefit. Subgroup analyses were performed across various clinically relevant subgroups. RESULTS: Overall, csPCa was detected in 2154 (47%) patients. The models exhibited satisfactory performance, demonstrating good discrimination (AUC ranging from 0.75 to 0.78, p < 0.001), adequate calibration, and high net benefit. The model described by Alberts showed the highest clinical utility for threshold probabilities between 10 and 20%. Subgroup analyses highlighted variations in models' performance, particularly when stratified according to PSA level, biopsy technique and PI-RADS version. CONCLUSIONS: We report a comprehensive external validation of risk prediction models for csPCa diagnosis in patients who underwent MRI-targeted and systematic biopsies. The model by Alberts demonstrated superior clinical utility and should be favored when determining the need for a prostate biopsy.

Departement of Urology Hôpital Cochin Paris France

Department of Radiology Jules Bordet Institute Erasme Hospital Hôpital Universitaire de Bruxelles Université Libre de Bruxelles Brussels Belgium

Department of Urology and Surgical Studies Faculty of Medicine University Hospital Ostrava Ostrava University Ostrava Czech Republic

Department of Urology Centre Hospitalier Universitaire de Reims Reims France

Department of Urology Città Della Salute E Della Scienza Di Torino University of Turin Turin Italy

Department of Urology Clinique Saint Augustin Bordeaux France

Department of Urology Cliniques de L'Europe Saint Elisabeth Brussels Belgium

Department of Urology Grenoble Alpes University Hospital Université Grenoble Alpes CNRS Grenoble INP TIMC Grenoble France

Department of Urology Hôpital Cavale Blanche CHRU Brest Brest France

Department of Urology Hôpital Européen Georges Pompidou Université de Paris Paris France

Department of Urology Hôpitaux Universitaires de Genève Geneva Switzerland

Department of Urology IRCCS Regina Elena National Cancer Institute Rome Italy

Department of Urology Jules Bordet Institute Erasme Hospital Hôpital Universitaire de Bruxelles Université Libre de Bruxelles Jules Bordet Institute HUB Rue Meylemeersch 90 1070 Brussels Belgium

Department of Urology La Croix du Sud Hospital Quint Fonsegrives France

Department of Urology Private Medical Center Klinika Wisniowa Zielona Góra Poland

Department of Urology Vivantes Klinikum Am Urban Berlin Germany

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