A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
研究概览
简要总结
This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.
详细描述
This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.
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
- 41 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer
- •Negative bone scan
- •Lymph nodes by CT or MRI
- •Adequate blood work
- •Performance Status - ECOG 0-1
- •Life expectancy of at least 10 years
- •>40 years of age
排除标准
- •Prior history of malignancy
- •Prior hormonal therapy or chemotherapy
- •Prior pelvic radiation therapy
- •Unable to tolerate lying still 5-10 minutes/day
研究组 & 干预措施
Treatment 1
External beam radiation therapy + 6 months total androgen ablation
干预措施: Flutamide (Eulexin) and Lupron or Zoladex (Drug)
Treatment 1
External beam radiation therapy + 6 months total androgen ablation
干预措施: External Beam Radiotherapy (Radiation)
Treatment 2
External beam radiation therapy
干预措施: External Beam Radiotherapy (Radiation)
结局指标
主要结局
To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
时间窗: Years
次要结局
- Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy(Years)
研究者
Anthony V. D'Amico, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute