Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 178
- 主要终点
- Disease free survival
研究概览
简要总结
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.
Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.
详细描述
Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
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
盲法说明
This is a randomized Radiation trial
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
- •Written informed consent obtained.
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
- •T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
- •T3 N0 M0, any Gleason Score, PSA ≤ 100
排除标准
- •Patients with unilateral or bilateral hip replacement.
- •Patients with active collagen vascular disease.
- •Patients with active inflammatory bowel disease.
- •Patients with previous radiotherapy to the pelvis.
- •Patients with ataxia telangiectasia.
- •Patients with nodal or distant metastases
结局指标
主要结局
Disease free survival
时间窗: 5 years
The primary outcome for this study is PSA biochemical disease free survival at 5 years.
次要结局
- Late GI and GU toxicities(6 month post completion of treatment to end of 5 year follow up)
- Quality of life outcome: Expanded Prostate Index Composite (EPIC)(Baseline (start of treatment) to end of 5 year follow-up)
- Overall survival(Baseline to end of 5 year follow-up)
- Cancer specific survival(Baseline to end of 5 year follow-up)