Biparametric vs Multiparametric MRI for Prostate Cancer Diagnosis: The PRIME Diagnostic Clinical Trial.
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Ng Alexander B C D, Asif Aqua, Agarwal Ridhi, Panebianco Valeria, Girometti Rossano, Ghai Sangeet, Gómez-Gómez Enrique, Budäus Lars, Barrett Tristan, Radtke Jan Philipp, Kesch Claudia, De Cobelli Francesco, Pham Tho, Taneja Samir S, Hu Jim C, Tewari Ash, Rodríguez Cabello Miguel Á, Dias Adriano B, Mynderse Lance A, Borghi Marcelo, Boesen Lars, Singh Paras, Renard-Penna Raphaële, Leow Jeffrey J, Falkenbach Fabian, Pecoraro Martina, Giannarini Gianluca, Perlis Nathan, López-Ruiz Daniel, Kastner Christof, Schimmöller Lars, Rossiter Marimo, Nathan Arjun, Khetrapal Pramit, Chan Vinson Wai-Shun, Haider Aiman, Clarke Caroline S, Punwani Shonit, Brew-Graves Chris, Dickinson Louise, Mitra Anita, Brembilla Giorgio, Margolis Daniel J A, Takwoingi Yemisi, Emberton Mark, Allen Clare, Giganti Francesco, Moore Caroline M, Kasivisvanathan Veeru, PRIME Study Group Collaborators
Аннотация
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.