Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

• Compare the quality of life of participants treated with these regimens.

• Determine the association of biological molecular markers with the risk of prostate cancer, lung cancer, and colon cancer in these participants.

• Determine the relationship between the effects of these regimens on prostate cancer risk and genetic factors in these participants.

• Determine whether the effects of these regimens on prostate cancer risk are conditional upon pre-study use of these supplements by these participants.

• Determine whether the effects of these regimens are conditional upon intake of other nutrients, foods, and dietary supplements by these participants.

• Determine the effect of other dietary nutrients and dietary patterns on prostate cancer risk in these participants.

• Determine the effects of these regimens on the reduction of Alzheimer's disease incidence in these participants.

• Determine whether these regimens reduce the risk of age-related macular degeneration or cataract in these participants.

OUTLINE: This is a randomized, double-blind, multicenter study. Participants are randomized to one of four prevention arms.

• Arm I: Participants receive 2 different oral placebos once daily.

• Arm II: Participants receive oral selenium and oral placebo once daily.

• Arm III: Participants receive oral vitamin E and oral placebo once daily.

• Arm IV: Participants receive oral selenium and oral vitamin E once daily. Treatment continues for 7-12 years in the absence of unacceptable toxicity or diagnosis of prostate cancer.

Quality of life is assessed at baseline and then at 1, 3, 5, and 7 years.

Participants are followed annually.

PROJECTED ACCRUAL: A total of 32,400 participants (8,100 per prevention arm) will be accrued for this study within 5 years.

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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Eric Klein

Study Chair

Michael Benjamin Atkins

Study Chair

Philip J. Walther

Study Chair

Laurence H. Klotz

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006392
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top