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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Other: placebo; Drug: selenium

• Registration Number: NCT00217516
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2008-02
• Study Completion: 2008-10
• Status Verified: 2010-09
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	Patients receive oral placebo for 3-6 weeks.
Arm I	selenium	Patients receive oral selenium for 3-6 weeks.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States