NCT00673205已完成3 期
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,588
- 试验地点
- 1
- 主要终点
- Time to clinical progression
研究概览
简要总结
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Clinical diagnosis of non-metastatic cancer of the prostate gland
- •Patient to be 18 years and above
排除标准
- •Previous systemic therapy for prostate cancer
- •Previous history of another form of cancer (not prostate) within 5 years of study start.
研究组 & 干预措施
A
Placebo Comparator
干预措施: Placebo (Drug)
B
Active Comparator
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Time to clinical progression
时间窗: Throughout study period
Tolerability in terms of adverse events and laboratory parameters
时间窗: Throughout study period
次要结局
- Survival(Throughout study period)
- Time to treatment failure(Throughout study period)
- Prostate-specific antigen(Initial study period up to 2005 amended protocol)
研究者
研究点 (1)
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