Selenium in Preventing Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:
• * PSA level above the absolute value of 4 ng/mL or above a published age-ethnic adjusted PSA level appropriate for the community
• * Rising PSA that should represent a clinically significant PSA velocity (e.g., an estimated annual change in the PSA velocity ≥ 0.75 ng/mL)
• * Abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
• * Documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
• Prostate biopsy negative for cancer within the past 12 months
• Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN)
• * PIN allowed provided it is grade 1
• PATIENT CHARACTERISTICS:
• Creatinine \< 2 times upper limit of normal (ULN)
• Bilirubin \< 2 times ULN
• SGOT and SGPT \< 2 times ULN
• Alkaline phosphatase \< 2 times ULN
• No history of a prior malignancy except for the following:
• * Adequately treated basal cell or squamous cell carcinoma
• * Adequately treated (i.e., complete surgical removal with negative margins) stage I cancer from which the patient is currently in complete remission
• * Any other cancer from which the patient has been disease-free for 5 years
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No prior systemic chemotherapy or radiotherapy
• At least 90 days since prior and no other concurrent selenium \> 55 μg/day as a dietary supplement (including multivitamin supplements)
• More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)