S0000 Selenium and Vitamin E in Preventing Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIPreventionClosed55 and over (50 and over for African Americans)NCI, OtherCDR0000068277
S0000, U10CA037429, SWOG-S0000, CAN-NCIC-S0000, CALGB-S0000, ECOG-S0000, NCCAM, NCI-P00-0172, NCT00006392

Trial Description


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


  • 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


  • 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



  • See Disease Characteristics

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Systolic blood pressure < 160 mm Hg
  • Diastolic blood pressure < 90 mm Hg
  • No history of hemorrhagic stroke


  • No malignancies within the past 5 years except basal cell or squamous cell skin cancer
  • No uncontrolled medical illness
  • No retinitis pigmentosa


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • 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

  • National Cancer Institute
  • Eastern Cooperative Oncology Group
  • Cancer and Leukemia Group B
  • NCIC-Clinical Trials 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 Identifier NCT00006392
ClinicalTrials.gov processed this data on January 22, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.