Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
- 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
- Arm II: Patients receive oral placebo for 3-6 weeks. Patients then undergo
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
Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment
1 and 6 months after completion of study treatment
Michael R. Kuettel, MD, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|