A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,204
- 试验地点
- 50
- 主要终点
- Biochemical (PSA) Failure
研究概览
简要总结
This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.
详细描述
In this trial, men with intermediate risk prostate cancer will be randomized to a shorter course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard). Three-dimensional conformal radiation treatment techniques, including intensity modulated radiotherapy will be used for both hypofractionated and standard treatments to avoid normal tissue exposure to radiation and minimize the risk of acute and late treatment related toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality from cancer, toxicity and health-related quality of life. It is planned to recruit 1204 patients to the study. If the safety and efficacy of the shorter course are demonstrated, then its adoption would reduce the social, emotional and economic burden of treatment for patients and their families.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
- •Intermediate risk prostate cancer (that is, T1-2a, Gleason score <6, PSA 10.1-20.0 ng/ml; T2b-c Gleason <6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml).
排除标准
- •Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
- •Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
- •Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
- •Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;
- •Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
- •Previous pelvic radiotherapy;
- •Inflammatory bowel disease.
研究组 & 干预措施
1
6000 cGy / 20 fractions in 4 weeks
干预措施: 6000 cGy/20 fractions in 4 weeks (Procedure)
2
7800 cGy / 39 fractions in 8 weeks
干预措施: 7800 cGy/39 fractions in 8 weeks (Procedure)
结局指标
主要结局
Biochemical (PSA) Failure
时间窗: five years
次要结局
- Prostate Cancer Specific Mortality(five years)
- Toxicity(five years)
- Quality of Life(five years)
- Biochemical-Clinical Failure(five years)