NCT00855647已完成2 期
Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99,999
- 试验地点
- 2
- 主要终点
- PSA response that achieves a stable nadir over time.
研究概览
简要总结
To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eligible patients will have clinical stage T1c through T2b, initial PSA level <10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved.
- •Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
- •Adult men will be considered.
- •No life expectancy restrictions will apply.
- •Performance Status will not be considered.
- •No requirements for organ or marrow function will be made
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •No prior prostate treatment will be allowed.
- •The use of other concurrent Investigational Agents will not be allowed.
- •No exclusion requirements due to co-morbid disease or incurrent illness.
- •No requirements regarding history of allergic reactions.
- •Pregnancy or nursing patients is not applicable (ie. patients are male).
结局指标
主要结局
PSA response that achieves a stable nadir over time.
次要结局
未报告次要终点
研究者
研究点 (2)
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