Hamm Charlie A, Asbach Patrick, Pöhlmann Anna, Schoots Ivo G, Kasivisvanathan Veeru, Henkel Thomas O, Johannsen Manfred, Speck Thomas, Baur Alexander D J, Haas Matthias, Collettini Federico, Penzkofer Tobias, Savic Lynn J, Konietschke Frank, Weißbach Lothar, Hamm Bernd, König Frank, Cash Hannes
Department of Radiology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Berlin Institute of Health (BIH), Berlin, Germany.
JAMA Oncol. 2025 Feb 1;11(2):145-153. doi: 10.1001/jamaoncol.2024.5497.
The magnetic resonance imaging (MRI) pathway for diagnosing clinically significant prostate cancer (csPCa; defined as International Society of Urological Pathology grade group ≥2) uses multiparametric MRI (mpMRI) for prostate biopsy (PB) decision-making. However, the intermediate impact on patient outcomes in men with negative MRI results avoiding PB and men with positive MRI results without PCa remains unknown.
To assess the feasibility and safety of a community-based MRI diagnostic strategy in men with suspected PCa using 3-year active monitoring.
DESIGN, SETTING, AND PARTICIPANTS: This multisite, longitudinal cohort trial took place across 54 community-based urology practices and 2 radiology imaging centers at a referral academic institution in Berlin, Germany. Eligible participants aged 18 to 75 years with clinically suspected PCa were enrolled between September 2016 and December 2017 and monitored for 3 years. Final analysis was reported on December 23, 2023.
Participants underwent 3-T mpMRI. Men with findings suspected to be PCa were recommended for targeted PB (diagnostic phase). Men with negative mpMRI results or positive mpMRI results with benign findings at PB were systematically monitored for 3 years (monitoring phase). Clinical visits were recommended every 6 months.
The total proportion of men avoiding PB and those with csPCa.
A total of 593 men (median [IQR] age, 64 [58-70] years) underwent mpMRI, with 286 (48%) having negative MRI results, 261 (44%) avoiding PB initially, and 242 (41%) avoiding PB over 3 years. csPCa was detected in 161 (27%) men after immediate PB, increasing to 172 (29%) men after 3 years. Seven men with negative MRI results were diagnosed with PCa by immediate PB (including 4 cases of csPCa), while 279 entered monitoring. Three-year monitoring was completed by 233 (84%) men, with 7 diagnoses of csPCa. Of 307 men with positive MRI results, 58 (19%) showed no PCa after immediate PB, of which 41 (71%) completed monitoring and 4 (7%) were diagnosed with csPCa.
In this cohort study, men with negative mpMRI results avoiding biopsy were not at elevated risk of csPCa. The study confirms the oncological safety of the prebiopsy MRI strategy of avoiding an immediate PB after negative MRI results when a programmatic safety net is in place.
用于诊断临床显著前列腺癌（csPCa；定义为国际泌尿病理学会分级组≥2）的磁共振成像（MRI）途径采用多参数MRI（mpMRI）来进行前列腺活检（PB）决策。然而，对于MRI结果为阴性从而避免PB的男性以及MRI结果为阳性但无前列腺癌的男性，其对患者预后的中期影响仍不明确。
通过3年的主动监测，评估基于社区的MRI诊断策略在疑似前列腺癌男性中的可行性和安全性。
设计、设置和参与者：这项多中心纵向队列试验在德国柏林一家转诊学术机构的54个社区泌尿外科诊所和2个放射影像中心进行。2016年9月至2017年12月期间，纳入了年龄在18至75岁、临床疑似前列腺癌的符合条件参与者，并对其进行了3年监测。最终分析报告于2023年12月23日。
参与者接受了3-T mpMRI检查。对发现疑似前列腺癌的男性建议进行靶向PB（诊断阶段）。对mpMRI结果为阴性或mpMRI结果为阳性但PB时发现为良性的男性进行了3年的系统监测（监测阶段）。建议每6个月进行一次临床随访。
避免PB的男性以及患有csPCa的男性的总比例。
共有593名男性（中位[四分位间距]年龄，64[58 - 70]岁）接受了mpMRI检查，其中286名（48%）MRI结果为阴性，261名（44%）最初避免了PB，242名（41%）在3年中避免了PB。立即进行PB后，161名（27%）男性被检测出患有csPCa，3年后这一数字增至172名（29%）。7名MRI结果为阴性的男性通过立即PB被诊断为前列腺癌（包括4例csPCa），279名进入监测阶段。233名（84%）男性完成了3年监测，其中7名被诊断为csPCa。在307名MRI结果为阳性的男性中，58名（19%）在立即PB后未发现前列腺癌，其中41名（71%）完成了监测，4名（7%）被诊断为csPCa。
在这项队列研究中，MRI结果为阴性而避免活检的男性发生csPCa的风险并未升高。该研究证实，当有程序性安全保障措施时，活检前MRI策略（即MRI结果为阴性后避免立即进行PB）在肿瘤学方面是安全的。
