PROJECT#2: MRI-guided Local SBRT Prostate Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Biochemical Relapse-Free Survival
研究概览
简要总结
The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
详细描述
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Optimal Inclusion Criteria
- •Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria .
- •No prior radiation therapy to the target areas
- •Expected patient survival >5 years
- •Patient able to undergo a MRI exam
- •Cautionary Inclusion Criteria
- •Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, >60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications.
- •Patients with higher risk but low volume disease not candidates for ENI may be treated on an individual basis
排除标准
- •Prior radiation therapy to the target areas
- •Expected patient survival below 5 years
- •Patient unable to undergo a MRI exam
结局指标
主要结局
Biochemical Relapse-Free Survival
时间窗: 5-years
To achieve a 4-year biochemical relapse-free survival of 95%.
Adverse Events
时间窗: 5-years
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
次要结局
- Quality of Life (QOL) assessment(5-years)