NCT06054867进行中（未招募）不适用
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
PROCEPT BioRobotics5 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年3月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical Stage ≤ T2c
- •PSA ≤ 20 ng/ml
- •Prostate volume ≥ 30 ml
- •Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.
排除标准
- •Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy.
- •Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months.
- •Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
- •Evidence of bone metastasis.
- •Evidence of extracapsular involvement.
- •Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with"
- •Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.
结局指标
主要结局
Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.
时间窗: 12 months post-treatment
The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.
次要结局
未报告次要终点
研究者
研究点 (5)
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