He Bi-Ming, Xue Wei, Yan Wei-Gang, Yin Lei, Dong Bai-Jun, Zhou Zhi-En, Lin Heng-Zhi, Zhou Yi, Wang Yan-Qing, Shi Zhen-Kai, Zhou Hai, Wang Shuai-Dong, Ren Shan-Cheng, Gao Xu, Wang Lin-Hui, Xu Chuan-Liang, Wang Hai-Feng
Department of Urology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Front Oncol. 2021 Nov 10;11:760003. doi: 10.3389/fonc.2021.760003. eCollection 2021.
The classical pathway for the therapy of low- to intermediate-risk localized prostate cancer is radical prostatectomy or radiation therapy, which has shown a high incidence of complications, including erectile dysfunction, urinary incontinence, and bowel injury. An alternative pathway is to perform an ablation by some energy to the localized lesion, known as focal therapy. High-frequency irreversible electroporation (H-FIRE) is nonthermal energy that can be used in cancer ablation to deliver pulsed high-voltage but low-energy electric current to the cell membrane and to invoke cell death. An H-FIRE pathway has been reported to be tissue-selective, which leads to fewer side effects.
This is a multicenter and single-arm objective performance criteria (OPC) study, in which all men with localized prostate cancer are allocated to H-FIRE ablation. This trial will assess the efficacy and safety of the H-FIRE ablation for prostate cancer. Efficacy will be assessed by prostate biopsy 6 months after treatment while safety will be assessed by adverse event reports and questionnaires. The main inclusion criteria are moderate to low-risk prostate cancer in NCCN risk classification and had no previous therapy for prostate cancer. A sample size of 110 participants is required. The primary objective is to determine whether the detection rate of clinically significant cancer by prostate biopsy is less than 20% after the H-FIRE ablation.
This study has obtained ethical approval by the ethics committee of all participating centers. The results of the study will be submitted for dissemination and publication in peer-reviewed journals.
This multicenter single-arm objective performance criteria trial will evaluate the efficacy and safety of the use of high-frequency irreversible electroporation in treating prostate cancer.
A comprehensive evaluation of imaging and histopathology is used to determine the effect of treatment. Questionnaires were used to assess the treatment side effects. Multicenter and pragmatic designs capacitate higher generalizability. A limitation of this trial is that the prostate biopsy as an endpoint may not be as accurate as of the specimen from prostate prostatectomy. Another limitation is the 6-month follow-up time, making this trial challenging to come to firm conclusions regarding the efficacy and safety of IRE in the long term.
ClinicalTrials.gov, NCT03838432.
低至中危局限性前列腺癌的经典治疗途径是根治性前列腺切除术或放射治疗，这些治疗已显示出高并发症发生率，包括勃起功能障碍、尿失禁和肠道损伤。另一种途径是通过某种能量对局限性病变进行消融，即聚焦治疗。高频不可逆电穿孔（H-FIRE）是非热能，可用于癌症消融，向细胞膜输送脉冲高电压但低能量电流并引发细胞死亡。据报道，H-FIRE途径具有组织选择性，副作用较少。
这是一项多中心单臂客观性能标准（OPC）研究，所有局限性前列腺癌男性患者均被分配接受H-FIRE消融治疗。本试验将评估H-FIRE消融治疗前列腺癌的疗效和安全性。治疗6个月后通过前列腺活检评估疗效，通过不良事件报告和问卷调查评估安全性。主要纳入标准为NCCN风险分类中的中低危前列腺癌且既往未接受过前列腺癌治疗。需要110名参与者的样本量。主要目标是确定H-FIRE消融治疗后前列腺活检临床显著癌症的检出率是否低于20%。
本研究已获得所有参与中心伦理委员会的伦理批准。研究结果将提交以供在同行评审期刊上传播和发表。
这项多中心单臂客观性能标准试验将评估使用高频不可逆电穿孔治疗前列腺癌的疗效和安全性。
采用影像学和组织病理学的综合评估来确定治疗效果。使用问卷调查来评估治疗副作用。多中心和务实设计使研究具有更高的普遍性。本试验的一个局限性是，作为终点的前列腺活检可能不如前列腺切除标本那样准确。另一个局限性是6个月的随访时间，这使得本试验难以就IRE长期的疗效和安全性得出确凿结论。
ClinicalTrials.gov，NCT03838432
