NCT00321620已完成3 期
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory 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
- Amgen
- 入组人数
- 1,904
- 主要终点
- Time to the First On-Study SRE (Non-inferiority)
研究概览
简要总结
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men >/= 18 years of age with histologically confirmed prostate cancer
- •Radiographic evidence of at least one bone metastasis
- •Failure of at least one hormonal therapy as evidenced by a rising PSA
- •Serum testosterone level of <50 ng/dL
- •ECOG PS 0, 1, or 2
- •Adequate organ function
排除标准
- •Current or prior IV bisphosphonate administration
- •Current or prior oral bisphosphonates for bone mets
- •Life expectancy of less than 6 months
研究组 & 干预措施
zoledronic acid
Active Comparator
干预措施: zoledronic acid (Drug)
denosumab
Experimental
干预措施: denosumab (Biological)
结局指标
主要结局
Time to the First On-Study SRE (Non-inferiority)
时间窗: Up to 40.5 months
Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
次要结局
- Time to the First On-Study SRE (Superiority)(Up to 40.5 months)
- Time to the First-And-Subsequent On-Study SRE(Up to 40.5 months)
研究者
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