S0000 Selenium and Vitamin E in Preventing Prostate Cancer

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)