Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study|
- 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 ]
- Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment [ Time Frame: 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 [ Time Frame: 1 and 6 months after completion of study treatment ]
|Study Start Date:||March 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral selenium for 3-6 weeks.
Placebo Comparator: Arm II
Patients receive oral placebo for 3-6 weeks.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217516
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Michael R. Kuettel, MD, PhD||Roswell Park Cancer Institute|