NCT01511874已完成4 期
Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects 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
- •Male of 20 years or above
- •Subject with prostate cancer with TNM stage T2~4NxMx
- •Blood testosterone concentration ≥ 100ng/dl
- •Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
- •WHO ECOG performance status ≤ 2
- •Signed written informed consent
排除标准
- •Hormone-Refractory Prostate cancer
- •Brain metastasis
- •Another primary malignant tumor except for prostate cancer
- •Other conditions which in the opinion of the investigator preclude enrollment into the study
研究组 & 干预措施
ELIGRAD 22.5mg
Experimental
a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
干预措施: ELIGARD 22.5mg (Drug)
结局指标
主要结局
Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
时间窗: 4weeks
次要结局
- Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks(24weeks)
- Change in ECOG performance status(0,4,8,12, 24weeks)
- Change in blood prostate-specific antigen(0,4,8,12,24 weeks)
- Change in QoL_EPIC grade(0,12, 24weeks)
- Change in penile length(screening, 12, 24weeks)
- Change in self assessment scale grade(0,4, 8, 12, 24 weeks)
- Change in testicular volume(screening, 12, 24weeks)
- Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks(24weeks)
- Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks(4, 24 weeks)
研究者
研究点 (1)
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