Conditions: Prostate Cancer
Keywords: prostate cancer
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 35533
Healthy volunteers: yes

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.

Arms:
arm 1: vitamin E and selenium placebo daily for 7-12 years arm 2: selenium and vitamin E placebo daily for 7-12 years arm 3: vitamin E and selenium placebo daily for 7-12 years arm 4: vitamine E placebo and selenium placebo daily for 7-12 years

Interventions: intervention 1: Vitamin E intervention 2: Selenium intervention 3: Vitamin E placebo intervention 4: selenium placebo
Intervention descriptions: intervention 1: 400 IU daily by mouth for 7-12 years intervention 2: 200 mcg daily for 7-12 years intervention 3: daily for 7-12 years intervention 4: daily for 7-12 years

Protocol document: