Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217516
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-09-20
Brief Title:
Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy Selenium Brachytherapy Trial Phase IPilot Study
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016056 | NIH | None | None |
| RPCI-I-14603 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |