Prostate cancer detection by MRI‐ultrasonography fusion transperineal vs transrectal biopsy: a randomised control trial

IF 3.7 2区医学 Q1 UROLOGY & NEPHROLOGY

BJU International Pub Date : 2025-06-27 DOI:10.1111/bju.16831

Nicola Schieda, Christopher Morash, Luke T. Lavallee, Trevor A. Flood, Ilias Cagiannos, Ehab Elzayat, Zoya Patni, Tim Ramsay, Rodney H. Breau

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引用次数: 0

Abstract

ObjectiveTo compare clinically significant prostate cancer (CS‐PCa) detection by transperineal (TP) compared to transrectal (TR) magnetic resonance imaging (MRI)‐ultrasonography (US) fusion prostate biopsy.Patients and MethodsMales with abnormal prostate MRI (one or more lesion[s], Prostate Imaging‐Reporting and Data System [PI‐RADS] score ≥3) consenting to prostate biopsy were enrolled in a randomised control trial (NCT03936127) performed at single‐site tertiary care referral centre from October 2022 to June 2024. The patients were randomised to either TP or TR biopsy approach. The primary outcome was CS‐PCa (International Society of Urogenital Pathology Grade Group ≥2). Subgroup analysis of the primary outcome was stratified by lesion location (posterior, anterior; and apex, middle, base) and PI‐RADS score. Secondary outcomes were detection of any grade PCa, infection, and patient pain score.ResultsIn total, 233 patients were randomised (119 patients with 168 lesions in the TP group and 114 patients with 151 lesions in the TR group). CS‐PCa was detected in: 61% (73/119; 95% confidence interval [CI] 52–70%) for TP and 54% (62/114; 95% CI 45–64%) for TR (relative risk [RR] 1.13, 95% CI 0.93–1.38, P = 0.23). Adjusted CS‐PCa detection rates were higher for TP in anterior lesions: 29% (95% CI 15–49%) vs 16% (95% CI 7–31%) (RR 1.81, 95% CI 1.05–3.12; P = 0.03) and PI‐RADS score 4 lesions: 51% (95% CI 39–62%) vs 30% (95% CI 19–43%) (RR 1.77, 95% CI 1.13–2.76; P = 0.01), with no difference in apical lesions (RR 0.91, 95% CI 0.60–1.37; P = 0.65). The median (interquartile range) pain score was 3 (2–4) in the TP group and 2 (1–5) in the TR group (P = 0.09). There were no urinary tract infections or urosepsis events in either group. No patient was withdrawn due to adverse events.ConclusionsIn this trial, we failed to demonstrate a statistically significant, increase in the detection of CS‐PCa using TP compared to TR biopsy. There were no sepsis events and biopsy was tolerated in both patient groups. MRI‐US fusion prostate biopsy using a TP approach may be more advantageous for anterior and smaller lesions, higher powered studies are needed.

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经会阴与经直肠活检融合MRI -超声检测前列腺癌：一项随机对照试验

目的比较经会阴（TP）与经直肠（TR）磁共振成像(MRI) -超声检查（US）融合前列腺活检对临床意义重大的前列腺癌（CS‐PCa）的检测效果。患者和方法前列腺MRI异常（一个或多个病变，前列腺成像报告和数据系统[PI - RADS]评分≥3）同意前列腺活检的男性被纳入一项随机对照试验（NCT03936127），该试验于2022年10月至2024年6月在单点三级保健转诊中心进行。患者随机选择TP或TR活检方法。主要终点为CS‐PCa（国际泌尿生殖病理学会分级组≥2级）。亚组分析的主要结局是根据病变位置(后方，前方；以及先端、中间、基部)和PI - RADS评分。次要结果是检测到任何级别的PCa、感染和患者疼痛评分。结果共纳入233例患者（TP组119例，168个病变；TR组114例，151个病变）。CS‐PCa在：61% (73/119；95%可信区间[CI] 52-70%), 54% (62/114；（相对危险度[RR] 1.13, 95% CI 0.93-1.38, P = 0.23）。前病变中TP的校正CS‐PCa检出率更高：29% (95% CI 15-49%) vs 16% (95% CI 7-31%) (RR 1.81, 95% CI 1.05-3.12；P = 0.03)和PI‐RADS评分4个病变：51% (95% CI 39-62%) vs 30% (95% CI 19-43%) (RR 1.77, 95% CI 1.13-2.76；P = 0.01)，根尖病变无差异(RR 0.91, 95% CI 0.60-1.37；P = 0.65)。TP组疼痛评分中位数（四分位间距）为3（2 - 4）分，TR组为2（1-5）分（P = 0.09）。两组均未发生尿路感染或尿脓毒症事件。没有患者因不良事件而退出。结论在本试验中，我们未能证明与TR活检相比，TP检测CS - PCa有统计学意义的增加。两组患者均无脓毒症发生，活检耐受。采用TP入路的MRI - US融合前列腺活检可能对前路和较小病变更有利，需要更有力的研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BJU International 医学-泌尿学与肾脏学

CiteScore

9.10

自引率

4.40%

发文量

262

审稿时长

1 months

期刊介绍： BJUI is one of the most highly respected medical journals in the world, with a truly international range of published papers and appeal. Every issue gives invaluable practical information in the form of original articles, reviews, comments, surgical education articles, and translational science articles in the field of urology. BJUI employs topical sections, and is in full colour, making it easier to browse or search for something specific.