NCT02042807进行中（未招募）2 期
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 702
- 试验地点
- 1
- 主要终点
- Cumulative biopsy-detectable prostate cancer rate
研究概览
简要总结
To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •high-risk subjects of prostate cancer.
- •Male subject with age from 50 to 75 years old.
- •Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF).
排除标准
- •Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function.
- •Subjects with a PSA > 10.0 ng/ml.
- •Subjects with a history of prostate cancer.
- •Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period.
- •Subjects are considered ineligible for the study as judged by the investigator.
研究组 & 干预措施
Placebo
Placebo Comparator
placebo arm
干预措施: Placebo (Drug)
MCS® 15 mg/day
Active Comparator
MCS® soft capsule
干预措施: MCS® (Drug)
MCS® 30 mg/day
Active Comparator
MCS® soft capsule
干预措施: MCS® (Drug)
结局指标
主要结局
Cumulative biopsy-detectable prostate cancer rate
时间窗: Week 104 (Month 24)
次要结局
未报告次要终点
研究者
研究点 (1)
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