Fujihara Atsuko, Shiraishi Takumi, Horiguchi Go, Ueda Takashi, Miyashita Masatsugu, Inoue Yuta, Iwami Yayoi, Naito Akari, Teramukai Satoshi, Ito-Ihara Toshiko, Ukimura Osamu
Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Int J Surg Protoc. 2025 Jun 18;29(3):93-101. doi: 10.1097/SP9.0000000000000051. eCollection 2025 Sep.
Focal therapy (FT) for localized prostate cancer (PC) aims to achieve cancer control and maintain quality of life. Microwave tissue coagulation (MTC) is a tissue-coagulation thermotherapy that has been used to treat solid tumors such as kidney, liver, and lung tumors. However, the use of this technology in lesion-targeted FT for PC has not been established.
We will perform a prospective multi-center, single-arm, clinical study to evaluate the efficacy and safety of lesion-targeted focal MTC for localized PC. In eight centers with expert urologists for performing magnetic resonance imaging (MRI)/ultrasound (US) fusion biopsy, patients will be evaluated prospectively after lesion-targeted MTC. The target sample size is 65. This study was registered with the Japan Registry of Clinical Trials and ClinicalTrials.gov. Inclusion criteria were patients who had a single MRI-visible lesion with Prostate Imaging Reporting and Data System (PI-RADS) category 3 or 4 that was proven as Gleason score of 7 or 8 cancer by enrollment biopsy or patients who had a single MRI-visible lesion with PI-RADS category 4 or 5 that was proven as Gleason score of 6 or 7 by enrollment biopsy. The primary endpoint is the disappearance of the targeted cancer lesion at 6 months after microwave coagulation, evaluated by a combined response in prostate-specific antigen, MRI, and prostate biopsy.
The importance of this clinical trial is to establish a new ablative treatment option for lesion-targeted FT in PC.
局部前列腺癌（PC）的聚焦治疗（FT）旨在实现癌症控制并维持生活质量。微波组织凝固（MTC）是一种组织凝固热疗法，已用于治疗实体肿瘤，如肾、肝和肺肿瘤。然而，该技术在PC的病灶靶向FT中的应用尚未确立。
我们将进行一项前瞻性多中心单臂临床研究，以评估病灶靶向聚焦MTC治疗局部PC的疗效和安全性。在八个有专家泌尿外科医生进行磁共振成像（MRI）/超声（US）融合活检的中心，对患者进行病灶靶向MTC治疗后进行前瞻性评估。目标样本量为65例。本研究已在日本临床试验注册中心和美国国立医学图书馆临床试验数据库注册。纳入标准为：经入组活检证实为Gleason评分7或8分癌症的、有单个MRI可见病灶且前列腺影像报告和数据系统（PI-RADS）分类为3或4类的患者，或经入组活检证实为Gleason评分6或7分癌症的、有单个MRI可见病灶且PI-RADS分类为4或5类的患者。主要终点是微波凝固后6个月时靶向癌灶的消失，通过前列腺特异性抗原、MRI和前列腺活检的综合反应进行评估。
这项临床试验的重要性在于为PC的病灶靶向FT建立一种新的消融治疗选择。
