NCT00006392 - S0000 Selenium and Vitamin E in Preventing Prostate Cancer | Crick

Overview

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: * Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer. * Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study. * Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

35,533

Conditions

Prostate Cancer

Interventions

Vitamin EDRUG

400 IU daily by mouth for 7-12 years

SeleniumDRUG

200 mcg daily for 7-12 years

Vitamin E placeboOTHER

daily for 7-12 years

selenium placebo

Eligibility

Sex: MALEMin age: 50 YearsMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (13)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Midwest Center for Hematology/Oncology

Joliet, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants With Prostate Cancer

Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.

Time frame: Every six months for 7 to 12 years depending on when the participant was randomized.

Secondary Outcomes

Number of Participants With Lung Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

Time frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Number of Participants With Colorectal Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

Time frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Number of Participants With Any Diagnosis of Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.