NCT00375687Unknown不适用
Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.
详细描述
The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •preoperative PSA>20ng/ml
- •postoperative PSA >0.2 ng/ml
- •Gleason > 7
- •signated infomed consent
排除标准
- •neoadjuvant hormonaltherapy before RP
- •unstable cncomitant conditions
结局指标
主要结局
Survival
次要结局
- PSA dinamics
- quality of life
研究者
研究点 (2)
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