An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese 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
- 110
- 试验地点
- 10
- 主要终点
- Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
研究概览
简要总结
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •20 years or older
- •Has a histological confirmed prostate cancer
- •Has a screening serum testosterone above 1.5 ng/mL
- •Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
- •Has a screening PSA value of ≥2 ng/mL
- •Has a life expectancy of at least 168 days
排除标准
- •Current or previous hormone therapy
- •Is currently treated with 5-α-reductase inhibitor
- •Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- •Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
- •Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
- •Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
- •Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
研究组 & 干预措施
Degarelix
干预措施: Degarelix (Drug)
结局指标
主要结局
Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
时间窗: From Day 28 to Day 168
Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.
次要结局
- Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3(Day 3)
- Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28(From Day 0 to Day 28)
- Cumulative Probability of no PSA Failure(Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168)