Schieda Nicola, Morash Christopher, Lavallee Luke T, Flood Trevor A, Cagiannos Ilias, Elzayat Ehab, Patni Zoya, Ramsay Tim, Breau Rodney H
Department of Radiology and Surgery (Urology), The University of Ottawa, Ottawa, Ontario, Canada.
The Ottawa Hospital, Ottawa, Ontario, Canada.
BJU Int. 2025 Jun 27. doi: 10.1111/bju.16831.
To compare clinically significant prostate cancer (CS-PCa) detection by transperineal (TP) compared to transrectal (TR) magnetic resonance imaging (MRI)-ultrasonography (US) fusion prostate biopsy.
Males 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.
In 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 No patient was withdrawn due to adverse events.
In 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.
比较经会阴（TP）与经直肠（TR）磁共振成像（MRI）-超声（US）融合前列腺活检对临床显著前列腺癌（CS-PCa）的检测情况。
前列腺MRI异常（一个或多个病灶，前列腺影像报告和数据系统[PI-RADS]评分≥3）且同意进行前列腺活检的男性患者，纳入了2022年10月至2024年6月在单中心三级医疗转诊中心进行的一项随机对照试验（NCT03936127）。患者被随机分为TP或TR活检方法组。主要结局是CS-PCa（国际泌尿生殖病理学会分级组≥2）。主要结局的亚组分析按病灶位置（后部、前部；以及尖部、中部、基部）和PI-RADS评分进行分层。次要结局是任何分级前列腺癌的检测情况、感染情况以及患者疼痛评分。
总共纳入233例随机分组患者（TP组119例患者有168个病灶，TR组114例患者有151个病灶）。TP组CS-PCa检测率为61%（73/119；95%置信区间[CI]52-70%），TR组为54%（62/114；95%CI 45-64%）（相对风险[RR]1.13，95%CI 0.93-1.38，P = 0.23）。TP组在前部病灶中的校正CS-PCa检测率更高：29%（95%CI 15-49%）对16%（95%CI 7-31%）（RR 1.81，95%CI 1.05-3.12；P = 0.03），在PI-RADS评分4分的病灶中：51%（95%CI 39-62%）对30%（95%CI 19-43%）（RR 1.77，95%CI 1.13-2.76；P = 0.01），尖部病灶无差异（RR 0.91，95%CI 0.60-1.37；P = 0.65）。TP组的中位（四分位间距）疼痛评分为3（2-4），TR组为2（1-5）（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退出。
在本试验中，我们未能证明与TR活检相比，TP活检在CS-PCa检测方面有统计学显著增加。两组均未发生脓毒症事件，且两组患者均能耐受活检。采用TP方法的MRI-US融合前列腺活检对于前部和较小病灶可能更具优势，需要开展更有说服力的研究。
