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. 2025 Sep 10:e2513722.
doi: 10.1001/jama.2025.13722. Online ahead of print.

Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial

Alexander B C D Ng  1   2 , Aqua Asif  1   2 , Ridhi Agarwal  3 , Valeria Panebianco  4 , Rossano Girometti  5   6 , Sangeet Ghai  7   8 , Enrique Gómez-Gómez  9 , Lars Budäus  10   11 , Tristan Barrett  12 , Jan Philipp Radtke  13   14 , Claudia Kesch  15   16 , Francesco De Cobelli  17   18 , Tho Pham  19 , Samir S Taneja  20 , Jim C Hu  21 , Ash Tewari  22 , Miguel Á Rodríguez Cabello  23 , Adriano B Dias  7   8   24 , Lance A Mynderse  25 , Marcelo Borghi  26 , Lars Boesen  27   28 , Paras Singh  1   29 , Raphaële Renard-Penna  30   31 , Jeffrey J Leow  32   33   34 , Fabian Falkenbach  10   11 , Martina Pecoraro  4 , Gianluca Giannarini  35 , Nathan Perlis  36 , Daniel López-Ruiz  37 , Christof Kastner  38 , Lars Schimmöller  39   40 , Marimo Rossiter  1   2 , Arjun Nathan  1   2 , Pramit Khetrapal  1   2 , Vinson Wai-Shun Chan  1   2 , Aiman Haider  41 , Caroline S Clarke  42 , Shonit Punwani  43 , Chris Brew-Graves  43 , Louise Dickinson  44 , Anita Mitra  45 , Giorgio Brembilla  17   18 , Daniel J A Margolis  46 , Yemisi Takwoingi  3   47 , Mark Emberton  1 , Clare Allen  44 , Francesco Giganti  1   44 , Caroline M Moore  1   48 , Veeru Kasivisvanathan  1   2   48 ; PRIME Study Group Collaborators
Collaborators, Affiliations

Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial

Alexander B C D Ng et al. JAMA. .

Abstract

Importance: 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.

Objective: To assess whether biparametric MRI is noninferior to multiparametric MRI for diagnosis of clinically significant prostate cancer.

Design, setting, and participants: 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.

Interventions: 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.

Main outcomes and measures: 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%.

Results: 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.

Conclusion and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT04571840.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ng reported receiving grants from Prostate Cancer UK outside the submitted work. Dr Ghai reported receiving grants from University College London during the conduct of the study. Dr Budäus reported serving as a board member for EAU Section of Urological Imaging and Wolfgang.Dieckmann Stiftung. Dr Radtke reported receiving grants from Innovationsfonds of G-BA Germany, Novartis Pharmaceuticals, and Forschungskommission Heinrich-Heine-University Duesseldorf; receiving personal fees from Janssen Pharmaceuticals, Amgen, Apogepha, Astellas, AstraZeneca, Bayer, Bender Group, Johnson & Johnson, MedCom, and Philips Invivo; and receiving consulting fees from Dr Wolf, Beckelmann und Partner, Saegeling Medizintechnik, and Novartis Pharmaceuticals outside the submitted work. Dr Kesch reported receiving grants from Novartis, Amgen, and Mariana Oncology and receiving personal fees from Novartis, Pfizer, and Bayer outside the submitted work. Dr De Cobelli reported receiving personal fees from Bayer outside the submitted work. Dr Dias reported receiving a speakers fee from Bayer outside the submitted work. Dr Falkenbach reported receiving grants from Focal Healthcare outside the submitted work. Dr Chan reported receiving grants from Cancer Research UK and Leeds Hospital Charity and receiving nonfinancial support from BVM Medical Ltd outside the submitted work. Ms Brew-Graves reported receiving grants from Prostate Cancer K (which funded the trial and paid a proportion of Ms Brew-Graves’ salary during the conduct of the study). Dr Margolis reported receiving nonfinancial support from Stratagen Bio outside the submitted work. Dr Takwoingi reported receiving grants (to University of Birmingham via UCL) from Prostate Cancer UK during the conduct of the study. Dr Moore reported receiving grants from the National Institute for Health and Care Research (research professorship), Prostate Cancer UK, Medical Research Council, and SpectraCure and receiving and personal fees from SonaCare outside the submitted work. Dr Kasivisvanathan reported receiving grants from the John Black Charitable Foundation and Prostate Cancer UK, European Association of Urology Research Foundation, and Wolfgang.Dieckmann Foundation during the conduct of the study and serving as medical advisor to Telix Pharmaceuticals (no compensation yet received). No other disclosures were reported.

Comment in

  • doi: 10.1001/jama.2025.13914

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