TY - JOUR
T1 - Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis
T2 - The PRIME Diagnostic Clinical Trial
AU - PRIME Study Group Collaborators
AU - Ng, Alexander B C D
AU - Asif, Aqua
AU - Agarwal, Ridhi
AU - Panebianco, Valeria
AU - Girometti, Rossano
AU - Ghai, Sangeet
AU - Gómez-Gómez, Enrique
AU - Budäus, Lars
AU - Barrett, Tristan
AU - Radtke, Jan Philipp
AU - Kesch, Claudia
AU - De Cobelli, Francesco
AU - Pham, Tho
AU - Taneja, Samir S
AU - Hu, Jim C
AU - Tewari, Ash
AU - Rodríguez Cabello, Miguel Á
AU - Dias, Adriano B
AU - Mynderse, Lance A
AU - Borghi, Marcelo
AU - Boesen, Lars
AU - Singh, Paras
AU - Renard-Penna, Raphaële
AU - Leow, Jeffrey J
AU - Falkenbach, Fabian
AU - Pecoraro, Martina
AU - Giannarini, Gianluca
AU - Perlis, Nathan
AU - López-Ruiz, Daniel
AU - Kastner, Christof
AU - Schimmöller, Lars
AU - Rossiter, Marimo
AU - Nathan, Arjun
AU - Khetrapal, Pramit
AU - Chan, Vinson Wai-Shun
AU - Haider, Aiman
AU - Clarke, Caroline S
AU - Punwani, Shonit
AU - Brew-Graves, Chris
AU - Dickinson, Louise
AU - Mitra, Anita
AU - Brembilla, Giorgio
AU - Margolis, Daniel J A
AU - Takwoingi, Yemisi
AU - Emberton, Mark
AU - Allen, Clare
AU - Giganti, Francesco
AU - Moore, Caroline M
AU - Kasivisvanathan, Veeru
A2 - Vasdev, Nikhil
N1 - © 2025 American Medical Association. All rights reserved, including those for text and data mining, AI training, and similar technologies. This is the accepted manuscript version of an article which has been published in final form at https://doi.org/10.1001/jama.2025.13722
PY - 2025/9/10
Y1 - 2025/9/10
N2 - 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.
AB - 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.
KW - Humans
KW - Male
KW - Prostatic Neoplasms/diagnostic imaging
KW - Multiparametric Magnetic Resonance Imaging/methods
KW - Middle Aged
KW - Aged
KW - Prospective Studies
KW - Prostate-Specific Antigen/blood
KW - Prostate/pathology
KW - Magnetic Resonance Imaging/methods
KW - Biopsy
KW - Diffusion Magnetic Resonance Imaging
KW - Contrast Media
UR - https://www.scopus.com/pages/publications/105018005848
U2 - 10.1001/jama.2025.13722
DO - 10.1001/jama.2025.13722
M3 - Article
C2 - 40928788
SN - 0098-7484
VL - 334
SP - 1170
EP - 1179
JO - Journal of the American Medical Association (JAMA)
JF - Journal of the American Medical Association (JAMA)
IS - 13
ER -