A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measure of PSA (Prostate Specific Antigen)
研究概览
简要总结
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measure of PSA (Prostate Specific Antigen)
时间窗: Up to 12 months
Measure of PSA through treatment. PSA is expected to be undetectable (\<0.2 mg/ml) after prostatectomy and radiation therapy.
Number of symptomatic adverse anastomotic events
时间窗: Up to 12 months
Number of symptomatic anastomotic events related to pre-operative SBRT.
次要结局
- Mean Catheterization Time(Up to 4 weeks post surgery)
- Mean Hospital Stay(Up to 2 week post surgery)
- Quality of Life assessment(Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery)