NCT00969202Unknown1 期
Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
San Diego Radiosurgery2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PSA decline measured through laboratory testing.
研究概览
简要总结
The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.
The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Gleason score ≤ 6 and low volume Gleason 7 (3+4)
- •PSA < 10
- •Clinical Stage of T2a or less
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Prior radiation treatment for prostate cancer
- •Gleason score > 7
- •PSA > 10
- •Clinical Stage of T2b or greater
结局指标
主要结局
PSA decline measured through laboratory testing.
时间窗: One month following radiosurgery through 5 year follow up
次要结局
- Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.(One month following radiosurgery through 5 years follow up.)
研究者
研究点 (2)
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