NCT00006392
S0000 Selenium and Vitamin E in Preventing Prostate Cancer
PHASE3
COMPLETED
NCT00006392
INTERVENTIONAL
Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
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.
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)
Prostate Cancer
- PREVENTION
-
- Type: DRUG
- Name: Vitamin E
- Description: 400 IU daily by mouth for 7-12 years
- Arm Group Labels: Vitamin E + selenium, Vitamin E + selenium placebo
-
- Type: DRUG
- Name: Selenium
- Description: 200 mcg daily for 7-12 years
- Arm Group Labels: Selenium + vitamin E placebo, Vitamin E + selenium
-
- Type: OTHER
- Name: Vitamin E placebo
- Description: daily for 7-12 years
- Arm Group Labels: Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo
-
- Type: OTHER
- Name: selenium placebo
- Description: daily for 7-12 years
- Arm Group Labels: Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo
- SWOG Cancer Research Network