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.

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

Philip J. Walther

Study Chair

Laurence H. Klotz

Study Chair

Scott M. Lippman, M.D.

Study Chair

Ian M. Thompson, M.D.

Study Chair

J. Michael Gaziano, M.D.

Study Chair

Daniel D Karp, M.D.

Study Chair

Fadlo R. Khuri, M.D.

Study Chair

Michael M Lieber, M.D.

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006392
Information obtained from ClinicalTrials.gov on November 05, 2012

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