Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
研究概览
简要总结
The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.
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
- •Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
- •Maximum PSA value of 20 ng/ml.
排除标准
- •Evidence of distant metastasis (M1).
- •Prior systemic chemotherapy for any reason.
- •Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
- •Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
- •Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
- •Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
研究组 & 干预措施
Postop High Risk
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
干预措施: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE (Radiation)
Salvage Non-High Risk
Proton to 70.2 CGE
干预措施: Proton (prostate bed) to 70.2 CGE (Radiation)
Salvage High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
干预措施: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE (Radiation)
Postop Non-High Risk
Proton to 66.6 CGE
干预措施: Proton to 66.6 CGE (Radiation)
结局指标
主要结局
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
时间窗: 6 months after the end of radiation therapy
次要结局
- Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters(After radiation: every 6 months for 3 years, then annually for 20 years)