S0000 Selenium and Vitamin E in Preventing Prostate Cancer

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.

DISEASE CHARACTERISTICS:

- Healthy male volunteers

- Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed
within 364 days prior to study entry

- Participants with a suspicious DRE are ineligible even if a recent or subsequent
biopsy is negative for cancer

- Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry

- No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial
neoplasia

PATIENT CHARACTERISTICS:

Age:

- See Disease Characteristics

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- Systolic blood pressure < 160 mm Hg

- Diastolic blood pressure < 90 mm Hg

- No history of hemorrhagic stroke

Other:

- No malignancies within the past 5 years except basal cell or squamous cell skin
cancer

- No uncontrolled medical illness

- No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 7 years since prior randomization to SWOG-9217, with completion of
end-of-study biopsy requirement

- No additional concurrent selenium or vitamin E (contained in individual supplements,
antioxidant mix, or multivitamin)

- Concurrent multivitamins allowed (supplied on study)

- No concurrent anticoagulation therapy (e.g., warfarin)

- Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day)
allowed

- Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel

- Concurrent anti-hypertension medication allowed

- No concurrent participation in another study involving a medical, surgical,
nutritional, or life-style intervention (unless no longer receiving the intervention
and are in the follow-up phase only)