NCT01423474已完成不适用
Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Bowel related quality-of-life
研究概览
简要总结
The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Low or intermediate risk prostate cancer patients as defined by:
- •Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL
- •Age >= 18 years
排除标准
- •Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months
- •Prior pelvic radiotherapy
- •Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- •Diagnosis of bleeding diathesis
- •Large prostate (>90cm3) on imaging
- •Immunosuppressive medications
- •Inflammatory bowel disease
结局指标
主要结局
Bowel related quality-of-life
时间窗: 3 months
次要结局
- Patient Overall Quality of life(During radiotherapy, at 3 and 6 months, then every 6 months after)
- Genitourinary toxicity(During radiotherapy, at 3 and 6 months, then every 6 months after)
- PSA relapse rate(3 and 5 years)
- Gastrointestinal toxicity(During radiotherapy, at 3 and 6 months, then every 6 months after)
- Salvage androgen deprivation therapy rate(3 and 5 years)
研究者
Dr. Aldrich Ong
Radiation Oncologist
CancerCare Manitoba
研究点 (6)
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