近日，英国伦敦大学学院Veeru Kasivisvanathan团队研究了双参数与多参数MRI诊断前列腺癌症的准确性。相关论文于2025年9月10日发表在《美国医学会杂志》上。

多参数磁共振成像（MRI），有或没有前列腺活检，已成为诊断临床显著前列腺癌的标准护理。资源容量限制了广泛采用。双参数MRI省去了钆对比序列，是一种更短、更便宜的替代方法，为全球卫生系统节省了时间。

为了评估双参数MRI在诊断具有临床意义的前列腺癌方面是否优于多参数MRI，2022年4月至2023年9月，研究组进行了一项前瞻性、多中心、患者内部、非劣效性试验，研究对象是来自22个中心（12个国家）、临床怀疑前列腺癌（前列腺特异性抗原[PSA]水平升高和/或直肠指检结果异常）的未接受活检的男性，最后一次随访于2024年12月3日进行。参与者接受了多参数MRI检查，包括T2加权、弥散加权和动态对比增强（DCE）序列。放射科医生首先报告了简短的双参数MRI （T2加权和弥散加权），对DCE序列不知情。解盲后，放射科医生报告了完整的多参数MRI。如果双参数MRI或多参数MRI提示有临床意义的前列腺癌，则患者接受有针对性的活检，或不进行系统活检。主要终点是临床显著前列腺癌患者的比例。次要结局包括患有临床无关紧要的癌症的男性比例。非劣效性裕度为5%。

在555名被招募的男性中，490人被纳入主要结果分析。中位年龄为65 （IQR, 59-70）岁，中位PSA水平为5.6 (IQR, 4.4-8.0) ng/mL。直肠指检结果异常的比例为12.7%。双参数MRI不逊于多参数MRI， 490名男性中有143名（29.2%）检测到有临床意义的前列腺癌，而490名男性中有145名（29.6%）（差异为0.4个百分点；P = 0.50）。490名男性中，双参数MRI检测到临床无关紧要的癌症的有45名（9.2%），而使用多参数MRI的490名男性中有47名（9.6%）（差异为0.4个百分点）。中央质量控制显示99%的扫描具有足够的诊断质量。

研究结果表明，对于疑似前列腺癌的男性，如果图像质量足够，短时间的双参数MRI扫描，加或不加靶向活检，可能成为前列腺癌诊断的新标准。全球每年大约进行400万次前列腺MRI检查，采用双参数MRI可以大大提高扫描仪吞吐量并降低全球成本。

附：英文原文

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

Author: Alexander B.C.D. Ng, Aqua Asif, Ridhi Agarwal, Valeria Panebianco, Rossano Girometti, Sangeet Ghai, Enrique Gómez-Gómez, Lars Budus, 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, Raphale Renard-Penna, Jeffrey J. Leow, Fabian Falkenbach, Martina Pecoraro, Gianluca Giannarini, Nathan Perlis, Daniel López-Ruiz, Christof Kastner, Lars Schimmller, 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, Antonella Borrelli, Alberto Briganti, Alessandro Crestani, Alessandro Sciarra, Alex Evangelista, Alex Freeman, Alex Kirkham, Alexandre Zlotta, Ana Blanca Pedregosa, Anders Bjartell, Andrew Ryan, Angela Tong

Issue&Volume: 2025-09-10

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.

DOI: 10.1001/jama.2025.13722

Source: https://jamanetwork.com/journals/jama/fullarticle/2838799