NCT00657904已完成3 期
A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early 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
- 3,618
- 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 - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
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
- •Prostate cancer in the early stage of disease
- •Prostate removed and/or radiation therapy to the prostate area
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
1
Experimental
干预措施: Bicalutamide (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to clinical progression
时间窗: Throughout study period
Overall patient survival
时间窗: Throughout study period
次要结局
- Time to treatment failure(Throughout study period)
- Serum prostate-specific antigen(Initial study period up to 2006 amended protocol)
- Tolerability in terms of adverse events and laboratory parameters(Throughout study period)
研究者
研究点 (1)
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