NCT01744366已完成3 期
An Open-label, Multi-centre, Randomised, Parallel-group Trial, Comparing Efficacy and Safety of Degarelix One-month Dosing Regimen With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 29
- 主要终点
- Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
研究概览
简要总结
One month degarelix/comparator treatment for prostate cancer in Chinese population
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
- 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
- •Chinese male over 18 years
- •Adenocarcinoma of the prostate
- •Relevant disease status based on lab values and as judged by the physician
- •Life expectancy of at least a year
排除标准
- •Previous hormonal treatment for prostate cancer
- •Considered to be candidate for curative therapy
- •Risk or history of any serious or significant health condition
- •Has received an investigational drug within the last 28 days and no previous treatment with degarelix
研究组 & 干预措施
Degarelix
Experimental
Degarelix 240/80 mg
干预措施: Degarelix (Drug)
Goserelin
Active Comparator
Goserelin 3.6 mg
干预措施: Goserelin (Drug)
结局指标
主要结局
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
时间窗: Day 28 to Day 364
次要结局
- Proportion of patients with testosterone levels ≤0.5 ng/mL(at Day 3)
- Percentage change in prostate-specific antigen (PSA)(from baseline to Day 28)
- Changes in testosterone and PSA levels(Day 0 to 364)
- Significant changes in laboratory values(Day 0 to Day 364)
- Significant changes in vital signs(Day 0 to Day 364)
- Significant changes in body weight(Day 0 to Day 364)
- Frequency and severity of adverse events(Day 0 to Day 364)
- Cumulative probability of no PSA failure(Day 0 to Day 364)
研究者
研究点 (29)
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