Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00217516|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: selenium Other: placebo||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study|
|Study Start Date :||March 2005|
|Primary Completion Date :||February 2008|
|Study Completion Date :||October 2008|
Experimental: Arm I
Patients receive oral selenium for 3-6 weeks.
Placebo Comparator: Arm II
Patients receive oral placebo for 3-6 weeks.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|