A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Time to Disease Progression
研究概览
简要总结
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（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
研究组 & 干预措施
Arm 1
50 mg bicalutamide and 3.5 mg Dutasteride (IP)
干预措施: bicalutamide (Drug)
Arm 1
50 mg bicalutamide and 3.5 mg Dutasteride (IP)
干预措施: dutasteride (Drug)
Arm 2
50 mg bicalutamide and placebo
干预措施: placebo (Drug)
Arm 2
50 mg bicalutamide and placebo
干预措施: bicalutamide (Drug)
结局指标
主要结局
Time to Disease Progression
时间窗: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter \[ng/mL\] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
次要结局
- Time to Treatment Failure(Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42))
- Number of Participants With PSA Response(Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42))
- Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42(Baseline and Months 6, 12, 18, 21, and 42)
- Number of Participants With Metastatic Disease(Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42))