NCT00036556已完成3 期
A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 941
- 试验地点
- 461
- 主要终点
- Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
研究概览
简要总结
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic 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
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with prostate cancer.
- •Have a rising PSA while on hormone therapy or following surgical castration.
排除标准
- •Have evidence of distant metastatic disease on screening bone scan or CT scan.
- •Have received cytotoxic chemotherapy.
- •Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.
结局指标
主要结局
Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
时间窗: Every 12 weeks
次要结局
未报告次要终点
研究者
研究点 (461)
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