Status:
COMPLETED
Selenium in Treating Patients With Prostate Cancer
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 85 years
Phase:
PHASE2
Brief Summary
RATIONALE: Selenium may prevent or slow the growth of prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.
Detailed Description
OBJECTIVES: * To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate. * To investigate the ability of selenium to effectively modulate biomarker...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-proven adenocarcinoma of the prostate within the past 48 months
- Prostate-specific antigen \< 50 ng/mL
- Gleason score \< 8
- Currently undergoing "watchful waiting" for prostate cancer
- No metastatic disease
- PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 years
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No other malignancy within the past 5 years, except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer
- At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00752739
Start Date
August 1 2002
End Date
April 1 2007
Last Update
August 15 2012
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724