NCT00293670Unknown4 期
Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- Time To Progression (TTP)
研究概览
简要总结
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA > 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA > 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent
- •Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to < 10 ng/mL. If the baseline was < 20ng/mL, at least 50% decrease from the baseline measurement is required
排除标准
- •(run-in period):
- •Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status
结局指标
主要结局
Time To Progression (TTP)
次要结局
- Overall and prostate cancer-specific survival, time to treatment failure, quality of life
研究者
研究点 (1)
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