S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)
Prostate Cancer

About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring 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)
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Midwest Center for Hematology/Oncology
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Good Samaritan Hospital Cancer Treatment Center
- Bethesda North Hospital
- Tod Children's Hospital
- LaFortune Cancer Center at St. John Medical Center
- Geisinger Medical Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- U.T. Cancer Institute at University of Tennessee Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Vitamin E + selenium placebo
Selenium + vitamin E placebo
Vitamin E + selenium
Vitamin E placebo + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
selenium and vitamin E placebo daily for 7-12 years
vitamin E and selenium placebo daily for 7-12 years
vitamine E placebo and selenium placebo daily for 7-12 years