An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 35
- 主要终点
- Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
研究概览
简要总结
The study was a three-arm, active-control, multi-centre, parallel group study.
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
- •Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- •Baseline testosterone >1.5 ng/mL.
- •Life expectancy of at least 12 months.
排除标准
- 未提供
研究组 & 干预措施
degarelix 240/160 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
干预措施: Degarelix (Drug)
degarelix 240/80 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
干预措施: Degarelix (Drug)
Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
干预措施: Leuprolide 7.5 mg (Drug)
结局指标
主要结局
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
时间窗: 12 months
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
次要结局
- Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment(2 weeks)
- Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3(3 days)
- Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252(Day 252, Day 255, and Day 259)
- Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28(Days 14 and 28)
- Participants Grouped by Time to Prostate-specific Antigen Failure(12 months)
- Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)(Baseline to Day 364)
- The Mean Value of QTc Interval as Measured by Electrocardiogram(12 months)
- Participants With Markedly Abnormal Change in Vital Signs and Body Weight(12 months)