Status:
COMPLETED
Selenium in Preventing Prostate Cancer
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 79 years
Phase:
PHASE3
Brief Summary
RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in pr...
Detailed Description
OBJECTIVES: * To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer. * To determine whether Se supplementation inhibits the biochemical progression of prostate...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2004
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00978718
Start Date
August 1 2001
End Date
June 1 2004
Last Update
August 15 2012
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