Status:
COMPLETED
Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
Brief Summary
RATIONALE: The use of nutritional supplements, such as selenium, may stop prostate cancer from growing. Internal radiation, such as brachytherapy, uses radioactive material placed directly into or nea...
Detailed Description
OBJECTIVES: Primary * Compare the effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility, using tissue samples from biopsies before and after treatment, in patients un...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Must have undergone ≥ a sextant biopsy
- Clinical stage T1a-T2a disease
- Gleason score \< 8
- Prostate-specific antigen \< 20 ng/mL
- PATIENT CHARACTERISTICS:
- Age
- Not specified
- Performance status
- Not specified
- Life expectancy
- More than 5 years
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No other prior malignancy except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- No prior hormonal therapy
- Radiotherapy
- No prior radiotherapy
- Surgery
- Not specified
- Other
- More than 30 days since prior and no concurrent participation in another clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise)
- No selenium at doses \> 50 mcg/day as a dietary supplement, including multivitamin supplements
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00217516
Start Date
March 1 2005
End Date
October 1 2008
Last Update
February 9 2012
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001