Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
Overview
- Phase
- Phase 1
- Intervention
- selenium
- Conditions
- Prostate Cancer
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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 near a tumor to kill tumor cells. Giving selenium before brachytherapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase I trial is studying selenium to see how well it works compared to placebo in treating patients who are undergoing brachytherapy for stage I or stage II prostate cancer.
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 undergoing brachytherapy for stage I or II prostate cancer. Secondary * Determine the effects of selenium on antioxidant enzyme activities in these patients. * Determine, preliminarily, whether there is a threshold effect among patients with low baseline levels of selenium treated with this drug. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral selenium for 3-6 weeks. Patients then undergo brachytherapy. * Arm II: Patients receive oral placebo for 3-6 weeks. Patients then undergo brachytherapy. After completion of study treatment, patients are followed at 1 and 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral selenium for 3-6 weeks.
Intervention: selenium
Arm II
Patients receive oral placebo for 3-6 weeks.
Intervention: placebo
Outcomes
Primary Outcomes
Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment
Time Frame: 1 and 6 months after completion of study treatment
Secondary Outcomes
- Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment(1 and 6 months after completion of study treatment)
- Threshold effect among patients with low baseline levels of selenium at 1 and 6 months after completion of study treatment(1 and 6 months after completion of study treatment)