Wetterauer Christian, Matthias Marc, Pueschel Heike, Deckart Alexander, Bubendorf Lukas, Mortezavi Ashkan, Arbelaez Emilio, Jean Winkel David, Heye Tobias, Boll Daniel T, Merkle Elmar, Hayoz Stefanie, Seifert Helge H, Rentsch Cyrill A
Department of Urology, University Hospital Basel, Basel, Switzerland; Department of Medicine, Faculty of Medicine and Dentistry, Danube Private University, Krems, Austria; University of Basel, Basel, Switzerland.
Department of Urology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.
Eur Urol Focus. 2024 Mar;10(2):332-338. doi: 10.1016/j.euf.2024.02.006. Epub 2024 Feb 23.
BACKGROUND: This study investigates the use of biparametric magnetic resonance imaging (bpMRI) as primary opportunistic screening for prostate cancer (PCa) without using a prostate-specific antigen (PSA) cut-off. OBJECTIVE: The primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI. DESIGN, SETTING, AND PARTICIPANTS: Biopsy-naïve men aged over 45 yr were included. All participants underwent 3 Tesla bpMRI, PSA, and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3. Men with negative bpMRI but suspicious DRE or elevated PSA/PSA density had template biopsies. Preintended protocol adjustments were made after an interim analysis for PI-RADS 3 lesions: no biopsy and follow-up MRI after 6 mo and biopsy only if lesions persisted or upgraded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Biopsy results underwent a comparison using Fisher's exact test and univariable logistic regression to identify prognostic factors for positive biopsy. RESULTS AND LIMITATIONS: A total of 229 men were enrolled in this study, of whom 79 underwent biopsy. Among these men, 77 displayed suspicious PI-RADS lesions. PCa was detected in 29 participants (12.7%), of whom 21 had csPCa (9.2%). Biparametric MRI detected 21 csPCa cases, while PSA and DRE would have missed 38.1%. Protocol adjustment led to a 54.6% biopsy reduction in PI-RADS 3 lesions. Overall, in this cohort of men with a median PSA value of 1.26 ng/ml, 10.9 bpMRI scans were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing systematic biopsies. CONCLUSIONS: Opportunistic screening utilising bpMRI as a primary tool has higher sensitivity in detecting csPCa than classical screening methods. PATIENT SUMMARY: Screening with biparametric magnetic resonance imaging (bpMRI) and targeted biopsy identified clinically significant prostate cancer in every 11th man, regardless of the prostate-specific antigen (PSA) levels. Preselecting patients based on PSA >1 ng/ml and a positive family history of prostate cancer, as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.
背景：本研究调查了使用双参数磁共振成像（bpMRI）作为前列腺癌（PCa）的主要机会性筛查手段，而不采用前列腺特异性抗原（PSA）临界值。 目的：主要终点是评估使用bpMRI识别20例具有临床意义的前列腺癌（csPCa）患者的工作量和有效性。 设计、设置和参与者：纳入45岁以上未接受过活检的男性。所有参与者均接受了3特斯拉的bpMRI、PSA检测和直肠指检（DRE）。前列腺影像报告和数据系统（PI-RADS）≥3的参与者仅进行靶向活检。对PI-RADS 3级病变进行中期分析后进行了预先计划的方案调整：6个月后不进行活检，仅进行随访MRI检查，只有在病变持续存在或升级时才进行活检。 结果测量和统计分析：使用Fisher精确检验和单变量逻辑回归对活检结果进行比较，以确定活检阳性的预后因素。 结果和局限性：本研究共纳入229名男性，其中79人接受了活检。在这些男性中，77人显示出可疑的PI-RADS病变。29名参与者（12.7%）检测出PCa，其中21人患有csPCa（9.2%）。双参数MRI检测出21例csPCa病例，而PSA和DRE会漏诊38.1%。方案调整使PI-RADS 3级病变的活检减少了54.6%。总体而言，在这个中位PSA值为1.26 ng/ml的男性队列中，需要进行10.9次bpMRI扫描才能识别出1例csPCa患者。本研究的一个主要局限性是缺乏接受系统活检的对照队列。 结论：以bpMRI作为主要工具的机会性筛查在检测csPCa方面比传统筛查方法具有更高的敏感性。 患者总结：使用双参数磁共振成像（bpMRI）和靶向活检进行筛查，每11名男性中就有1人被诊断为具有临床意义的前列腺癌，无论其前列腺特异性抗原（PSA）水平如何。基于PSA>1 ng/ml、前列腺癌家族史阳性以及其他潜在血液检测结果对患者进行预选，可能会进一步提高bpMRI在这种情况下的有效性。
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