PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 8
- 主要终点
- Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
研究概览
简要总结
The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •International Prostate Symptom Score (IPSS) ≥ 8
- •Gleason Grade Group 1-3
- •Prostate-specific Antigen (PSA) ≤20ng/mL
- •Cancer stage less than or equal to T2c
排除标准
- •Patients with previous surgical treatment of benign prostatic hyperplasia
- •MRI evidence of extracapsular extension of cancer
- •Any severe illness that would prevent complete study participation or confound study results
研究组 & 干预措施
Aquablation
干预措施: Robotic Waterjet Treatment (Device)
结局指标
主要结局
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
时间窗: 3 months post-treatment
Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment.
次要结局
未报告次要终点