Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35,533
- 试验地点
- 13
- 主要终点
- Number of Participants With Prostate Cancer
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.
详细描述
OBJECTIVES:
- Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
- Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
- Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
干预措施: Vitamin E (Drug)
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
干预措施: selenium placebo (Other)
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
干预措施: Selenium (Drug)
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
干预措施: Vitamin E placebo (Other)
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
干预措施: Vitamin E (Drug)
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
干预措施: Selenium (Drug)
Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
干预措施: Vitamin E placebo (Other)
Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
干预措施: selenium placebo (Other)
结局指标
主要结局
Number of Participants With Prostate Cancer
时间窗: Every six months for 7 to 12 years depending on when the participant was randomized.
Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.
次要结局
- Number of Participants With Lung Cancer(Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.)
- Number of Participants With Colorectal Cancer(Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.)
- Number of Participants With Any Diagnosis of Cancer(Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.)
- Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival(Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.)
- Number of Participants With Serious Cardiovascular Events(Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.)