S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Vitamin E; Selenium; Vitamin E placebo; selenium placebo
Intervention description: 400 IU daily by mouth for 7-12 years; 200 mcg daily for 7-12 years; daily for 7-12 years; daily for 7-12 years
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35533.0
Sex: Male
Minimum age: 50 Years
Maximum age: 120 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: prostate cancer

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.
    

Eligibility criteria:

        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)