Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
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.
OBJECTIVES:
DISEASE CHARACTERISTICS:
Healthy male volunteers
Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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 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)
Chicago, Illinois 60611-3013, United States
Maywood, Illinois 60153, United States
Wilkes-Barre, Pennsylvania 18711, United States