Prostate Cancer Clinical Trial
Official title:
Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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