Multiparametric magnetic resonance imaging (MRI), with or without prostate biopsy, has become the standard of care for diagnosing clinically significant prostate cancer. Resource capacity limits widespread adoption. Biparametric MRI, which omits the gadolinium contrast sequence, is a shorter and cheaper alternative offering time-saving capacity gains for health systems globally.
To assess whether biparametric MRI is noninferior to multiparametric MRI for diagnosis of clinically significant prostate cancer.
A prospective, multicenter, within-patient, noninferiority trial of biopsy-naive men from 22 centers (12 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] level and/or abnormal digital rectal examination findings) from April 2022 to September 2023, with the last follow-up conducted on December 3, 2024.
Participants underwent multiparametric MRI, comprising T2-weighted, diffusion-weighted, and dynamic contrast-enhanced (DCE) sequences. Radiologists reported abbreviated biparametric MRI first (T2-weighted and diffusion-weighted), blinded to the DCE sequence. After unblinding, radiologists reported the full multiparametric MRI. Patients underwent a targeted biopsy with or without systematic biopsy if either biparametric MRI or multiparametric MRI was suggestive of clinically significant prostate cancer.
The primary outcome was the proportion of men with clinically significant prostate cancer. Secondary outcomes included the proportion of men with clinically insignificant cancer. The noninferiority margin was 5%.
Of 555 men recruited, 490 were included for primary outcome analysis. Median age was 65 (IQR, 59-70) years and median PSA level was 5.6 (IQR, 4.4-8.0) ng/mL. The proportion of patients with abnormal digital rectal examination findings was 12.7%. Biparametric MRI was noninferior to multiparametric MRI, detecting clinically significant prostate cancer in 143 of 490 men (29.2%), compared with 145 of 490 men (29.6%) (difference, -0.4 [95% CI, -1.2 to 0.4] percentage points; P = .50). Biparametric MRI detected clinically insignificant cancer in 45 of 490 men (9.2%), compared with 47 of 490 men (9.6%) with the use of multiparametric MRI (difference, -0.4 [95% CI, -1.2 to 0.4] percentage points). Central quality control demonstrated that 99% of scans were of adequate diagnostic quality.
In men with suspected prostate cancer, provided image quality is adequate, an abbreviated biparametric MRI scan, with or without targeted biopsy, could become the new standard of care for prostate cancer diagnosis. With approximately 4 million prostate MRIs performed globally annually, adopting biparametric MRI could substantially increase scanner throughput and reduce costs worldwide.
ClinicalTrials.gov Identifier: NCT04571840.
JAMA. 2025 Sep 10 [Epub ahead of print]
Alexander B C D Ng, Aqua Asif, Ridhi Agarwal, Valeria Panebianco, Rossano Girometti, Sangeet Ghai, Enrique Gómez-Gómez, Lars Budäus, Tristan Barrett, Jan Philipp Radtke, Claudia Kesch, Francesco De Cobelli, Tho Pham, Samir S Taneja, Jim C Hu, Ash Tewari, Miguel Á Rodríguez Cabello, Adriano B Dias, Lance A Mynderse, Marcelo Borghi, Lars Boesen, Paras Singh, Raphaële Renard-Penna, Jeffrey J Leow, Fabian Falkenbach, Martina Pecoraro, Gianluca Giannarini, Nathan Perlis, Daniel López-Ruiz, Christof Kastner, Lars Schimmöller, Marimo Rossiter, Arjun Nathan, Pramit Khetrapal, Vinson Wai-Shun Chan, Aiman Haider, Caroline S Clarke, Shonit Punwani, Chris Brew-Graves, Louise Dickinson, Anita Mitra, Giorgio Brembilla, Daniel J A Margolis, Yemisi Takwoingi, Mark Emberton, Clare Allen, Francesco Giganti, Caroline M Moore, Veeru Kasivisvanathan, PRIME Study Group Collaborators
Division of Surgery and Interventional Science, UCL, London, United Kingdom., Department of Applied Health Sciences, University of Birmingham, Birmingham, United Kingdom., Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy., Institute of Radiology, Department of Medicine, University of Udine, Udine, Italy., Joint Department of Medical Imaging, University Medical Imaging Toronto, Toronto, Ontario, Canada., Urology Department Reina Sofia University Hospital, IMIBIC, Cordoba, Spain., Martini-Klinik Prostate Cancer Center, University Hospital-Hamburg-Eppendorf, Hamburg, Germany., Department of Radiology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom., Department of Urology, University Hospital Düsseldorf, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany., Department of Urology, University Hospital Essen, Essen, Germany., Department of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy., Monash University, Melbourne, Australia., New York University Grossman School of Medicine, New York., Brady Department of Urology, New York Presbyterian Weill Cornell Medicine Hospital, New York., Department of Urology, Icahn School of Medicine at Mount Sinai Hospital, New York., Department of Urology, Hospital Universitario Sanitas La Moraleja, Madrid, Spain., Mayo Clinic, Rochester, Minnesota., Centro de Urología, Buenos Aires, Argentina., Department of Urology and Urological Research, Herlev Gentofte University Hospital, Hellerup, Denmark., Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Paris, France., Department of Urology, Tan Tock Seng Hospital, Singapore., Urology Unit, University Hospital S. Maria della Misericordia, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Italy., Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Radiology Department Reina Sofia University Hospital, IMIBIC, Cordoba, Spain., Department of Urology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom., University Dusseldorf, Medical Faculty, Department of Diagnostic and Interventional Radiology, Dusseldorf, Germany., Department of Pathology, University College London Hospitals NHS Foundation Trust, London, United Kingdom., UCL Research Department of Primary Care and Population Health, University College London, London, United Kingdom., Centre for Medical Imaging, University College London, London, United Kingdom., Department of Radiology, University College London Hospitals NHS Foundation Trust, London, United Kingdom., Department of Clinical Oncology, UCLH NHS Foundation Trust, London, United Kingdom., Weill Cornell Medical College, New York, New York.