NCT00217516

Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer

Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	selenium	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-02-01
• Completion: 2008-10-01
• First posted: 2005-09-22
• Last updated: 2012-02-09

Locations

1 site across 1 country: United States