An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 26
- 主要终点
- Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
研究概览
简要总结
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
详细描述
An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.
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
- 未提供
排除标准
- •Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- •Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- •Eastern Cooperative Oncology Group (ECOG) score of ≤
- •Screening prostate-specific antigen (PSA) level ≥ ng/mL.
研究组 & 干预措施
A
Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
干预措施: Degarelix (Drug)
B
Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
干预措施: Degarelix (Drug)
结局指标
主要结局
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
时间窗: 1 year
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
次要结局
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight(Baseline up to 1 year)
- Serum Levels of Testosterone Over Time(1 year)
- Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364(1 year)
- Serum Levels of PSA Over Time(1 year)
- Probability of no PSA Failure(1 year)
- Serum Levels of Luteinizing Hormone (LH) Over Time(1 year)
- Liver Function Tests(1 year)
- Serum Levels of Follicle Stimulating Hormone (FSH) Over Time(1 year)