BACKGROUND AND OBJECTIVE: Biparametric magnetic resonance imaging (bpMRI), excluding dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), is a potential replacement for multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer (csPCa). An extensive international multireader multicase observer study was conducted to assess the noninferiority of bpMRI to mpMRI in csPCa diagnosis. METHODS: An observer study was conducted with 400 mpMRI examinations from four European centers, excluding examinations with prior prostate treatment or csPCa (Gleason grade [GG] ≥2) findings. Readers assessed bpMRI and mpMRI sequentially, assigning lesion-specific Prostate Imaging Reporting and Data System (PI-RADS) scores (3-5) and a patient-level suspicion score (0-100). The noninferiority of patient-level bpMRI versus mpMRI csPCa diagnosis was evaluated using the area under the receiver operating curve (AUROC) alongside the sensitivity and specificity at PI-RADS ≥3 with a 5% margin. The secondary outcomes included insignificant prostate cancer (GG1) diagnosis, diagnostic evaluations at alternative risk thresholds, decision curve analyses (DCAs), and subgroup analyses considering reader expertise. Histopathology and ≥3 yr of follow-up were used for the reference standard. KEY FINDINGS AND LIMITATIONS: Sixty-two readers (45 centers and 20 countries) participated. The prevalence of csPCa was 33% (133/400); bpMRI and mpMRI showed similar AUROC values of 0.853 (95% confidence interval [CI], 0.819-0.887) and 0.859 (95% CI, 0.826-0.893), respectively, with a noninferior difference of -0.6% (95% CI, -1.2% to 0.1%, p < 0.001). At PI-RADS ≥3, bpMRI and mpMRI had sensitivities of 88.6% (95% CI, 84.8-92.3%) and 89.4% (95% CI, 85.8-93.1%), respectively, with a noninferior difference of -0.9% (95% CI, -1.7% to 0.0%, p < 0.001), and specificities of 58.6% (95% CI, 52.3-63.1%) and 57.7% (95% CI, 52.3-63.1%), respectively, with a noninferior difference of 0.9% (95% CI, 0.0-1.8%, p < 0.001). At alternative risk thresholds, mpMRI increased sensitivity at the expense of reduced specificity. DCA demonstrated the highest net benefit for an mpMRI pathway in cancer-averse scenarios, whereas a bpMRI pathway showed greater benefit for biopsy-averse scenarios. A subgroup analysis indicated limited additional benefit of DCE MRI for nonexperts. Limitations included that biopsies were conducted based on mpMRI imaging, and reading was performed in a sequential order. CONCLUSIONS AND CLINICAL IMPLICATIONS: It has been found that bpMRI is noninferior to mpMRI in csPCa diagnosis at AUROC, along with the sensitivity and specificity at PI-RADS ≥3, showing its value in individuals without prior csPCa findings and prostate treatment. Additional randomized prospective studies are required to investigate the generalizability of outcomes.

Department of Circulation and Medical Imaging Norwegian University of Science and Technology Trondheim Norway; Department of Radiology and Nuclear Medicine St Olavs Hospital Trondheim University Hospital Trondheim Norway

Department of Diagnostic Sciences Ghent University Hospital Ghent Belgium

Department of Medical Imaging Andros Clinics Amsterdam The Netherlands

Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands

Department of Quantitative Health Sciences Cleveland Clinic Foundation Cleveland OH USA; Department of Diagnostic Radiology Cleveland Clinic Foundation Cleveland OH USA

Department of Radiological Sciences Oncology and Pathology Sapienza University of Rome Rome Italy

Department of Radiology University Medical Center Groningen Groningen The Netherlands; Department of Radiology Netherlands Cancer Institute Amsterdam The Netherlands

Department of Radiology Ziekenhuisgroep Twente Almelo The Netherland; Department of Multi Modality Medical Imaging Technical Medical Centre University of Twente Enschede The Netherlands

Department of Urinary and Vascular Imaging Hôpital Edouard Herriot Hospices Civils de Lyon Lyon France; Faculté de Médecine Lyon Est Université Lyon 1 Université de Lyon Lyon France

Department of Urology Erasmus Medical Center Rotterdam The Netherlands

Department of Urology Skåne University Hospital Lund Sweden; Division of Translational Cancer Research Lund University Cancer Centre Lund Sweden

Departments of Radiology Urology and Biomedical Data Science Stanford University Stanford CA USA

Diagnostic Image Analysis Group Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands

Diagnostic Image Analysis Group Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands; Department of Circulation and Medical Imaging Norwegian University of Science and Technology Trondheim Norway

Division of Artificial Medical Intelligence in Ophthalmology University of Colorado Boulder CO USA

Division of Medical Image Computing Deutsches Krebsforschungszentrum Heidelberg Germany; Pattern Analysis and Learning Group Department of Radiation Oncology Heidelberg University Hospital Heidelberg Germany

Division of Radiology Deutsches Krebsforschungszentrum Heidelberg Germany

Division of Surgery and Interventional Sciences University College London and University College London Hospital London UK

Martini Clinic Prostate Cancer Center University Medical Centre Hamburg Eppendorf Hamburg Germany

Minimally Invasive Image Guided Intervention Center Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands

Minimally Invasive Image Guided Intervention Center Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands; Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands

Minimally Invasive Image Guided Intervention Center Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands; Diagnostic Image Analysis Group Department of Medical Imaging Radboud University Medical Center Nijmegen The Netherlands

Paul Strickland Scanner Centre Mount Vernon Cancer Centre Northwood UK

Urology Unit Santa Maria della Misericordia University Hospital Udine Italy

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