SH Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China.
Prostate Cancer Prostatic Dis. 2023 Dec;26(4):736-742. doi: 10.1038/s41391-022-00577-8. Epub 2022 Jul 14.
To investigate the efficacy of transperineal targeted microwave ablation (TMA) in treating localized prostate cancer (PCa).
This is a single-centre prospective phase 2 trial recruiting men with low to intermediate-risk localized PCa to undergo transperineal TMA. TMA was performed with MRI-Ultrasound fusion guidance and organ-based tracking. A per-protocol 6-month MRI and biopsy were performed for all patients. The primary outcome was any cancer detected on biopsy of each ablated area. Secondary outcomes included per-patient analysis of positive biopsy, complications, urinary symptom score, erectile function and quality of life (QOL) scores.
In the first 15 men, 23 areas were being treated. The median age was 70 years, number of TMA ablations were 5 (range 2-8), and the total ablation time and operating time was 22 (IQR 14-28) and 75 (IQR 65-85) minutes, respectively. PSA level dropped from a median of 7.7 to 2.4 ng/mL. For the primary outcome, 91.3% (21/23) ablated area had no cancer in 6-month biopsy. In per-patient analysis, 33.3% (5/15) had in or out-of-field positive biopsy at 6 months. Among these five cases, four of them were amenable to active surveillance and 1 (6.7%) case with out-of-field ISUP grade group 2 cancer received radiotherapy. The urinary symptoms, uroflowmetry, erectile function, and QOL scores had no significant difference at 6 months. One patient (out of five patients with normal erection) in the cohort complained of significant worsening of erectile function after TMA. Grade 1 complications including hematuria (33.3%), dysuria (6.7%), and perineal discomfort (13.4%) were observed.
In this first pilot study, transperineal TMA guided by MRI-Ultrasound fusion guidance and organ-based tracking was shown to be effective, safe, and easily applicable in men with localized PCa.
探讨经会阴靶向微波消融(TMA)治疗局限性前列腺癌(PCa)的疗效。
这是一项单中心前瞻性 2 期临床试验,招募低危和中危局限性 PCa 男性患者行经会阴 TMA。TMA 采用 MRI-超声融合引导和器官跟踪技术进行。所有患者均进行协议规定的 6 个月 MRI 和活检。主要终点是每个消融区域活检发现的任何癌症。次要终点包括每位患者阳性活检、并发症、尿症状评分、勃起功能和生活质量(QOL)评分的分析。
在最初的 15 名男性中,共治疗了 23 个区域。中位年龄为 70 岁,TMA 消融次数为 5 次(范围 2-8 次),总消融时间和手术时间分别为 22(IQR 14-28)和 75(IQR 65-85)分钟。PSA 水平从中位数 7.7 降至 2.4ng/ml。主要终点方面,6 个月活检 91.3%(21/23)的消融区域无癌症。在每位患者的分析中,6 个月时 33.3%(5/15)有或无场域内阳性活检。在这 5 例中,有 4 例可接受主动监测,1 例(6.7%)场外 ISUP 分级组 2 级癌症患者接受放疗。6 个月时尿症状、尿流率、勃起功能和 QOL 评分无显著差异。在队列中,5 例勃起功能正常的患者中有 1 例(6.7%)抱怨 TMA 后勃起功能显著恶化。观察到 33.3%(5/15)的血尿、6.7%(1/15)的排尿困难和 13.4%(2/15)的会阴不适等 1 级并发症。
在这项首次试点研究中,经 MRI-超声融合引导和器官跟踪引导的经会阴 TMA 显示在局限性 PCa 男性中是有效、安全且易于应用的。