Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: S0000 Selenium and Vitamin E in Preventing Prostate Cancer

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.

Detailed 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.

Eligibility: 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)

Relevance to patient case: not relevant