NCT00403000已完成2 期
Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Time to disease progression
研究概览
简要总结
RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
详细描述
OBJECTIVES:
Primary
- Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride.
- Evaluate the toxicity of dutasteride in these patients.
Secondary
- Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride.
- Determine the survival of patients treated with dutasteride.
- Determine the quality of life of patients treated with dutasteride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to disease progression
时间窗: Every 12 weeks
Toxicity
时间窗: Daily while on Treatment
次要结局
- Objective response (complete and partial) rate and serum prostate-specific antigen levels(Every 4 weeks)
- Survival(Every 12 weeks)
研究者
研究点 (2)
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