Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments vitamin e, selenium, vitamin e placebo, selenium placebo
Phase phase 3
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2001
End date May 2011
Trial size 35533 participants
Trial identifier NCT00006392, CDR0000068277, NCT00076128, S0000, U10CA037429

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
vitamin E and selenium placebo daily for 7-12 years
vitamin e alpha tocopherol
400 IU daily by mouth for 7-12 years
selenium placebo placebo
daily for 7-12 years
(Experimental)
selenium and vitamin E placebo daily for 7-12 years
selenium L-selenomethionine
200 mcg daily for 7-12 years
vitamin e placebo placebo
daily for 7-12 years
(Experimental)
vitamin E and selenium placebo daily for 7-12 years
vitamin e alpha tocopherol
400 IU daily by mouth for 7-12 years
selenium L-selenomethionine
200 mcg daily for 7-12 years
(Placebo Comparator)
vitamine E placebo and selenium placebo daily for 7-12 years
vitamin e placebo placebo
daily for 7-12 years
selenium placebo placebo
daily for 7-12 years

Primary Outcomes

Measure
Number of Participants With Prostate Cancer
time frame: Every six months for 7 to 12 years depending on when the participant was randomized.

Secondary Outcomes

Measure
Number of Participants With Lung Cancer
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
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
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.
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
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 Serious Cardiovascular Events
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.

Eligibility Criteria

Male participants at least 50 years old.

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)

Additional Information

Official title Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.