NCT00693238已完成不适用
A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
研究概览
简要总结
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.
详细描述
Low Risk - Total of 70 Gy/CGE over 28 treatments
Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- •Previous prostate cancer surgery or pelvic radiation.
- •Prior or current chemotherapy for prostate cancer.
- •Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
- •History of proximal urethral stricture requiring dilatation.
- •History of hip replacement.
- •Diabetes requiring medication.
- •Prior intrapelvic surgery.
- •Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
- •On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
- •Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
结局指标
主要结局
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
时间窗: 6 months after the end of radiation therapy
次要结局
- Disease Control(20 years after end of radiation)
研究者
研究点 (2)
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