Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Overview
- Phase
- Phase 3
- Intervention
- Vitamin E
- Conditions
- Prostate Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 35533
- Locations
- 13
- Primary Endpoint
- Number of Participants With Prostate Cancer
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
Intervention: Vitamin E
Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
Intervention: selenium placebo
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
Intervention: Selenium
Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
Intervention: Vitamin E placebo
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
Intervention: Vitamin E
Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
Intervention: Selenium
Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
Intervention: Vitamin E placebo
Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
Intervention: selenium placebo
Outcomes
Primary Outcomes
Number of Participants With Prostate Cancer
Time Frame: 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.
Secondary Outcomes
- 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.)