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

Tracking Information
First Submitted Date ICMJE	September 20, 2005
First Posted Date ICMJE	September 22, 2005
Last Update Posted Date	February 9, 2012
Study Start Date ICMJE	March 2005
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 8, 2012)	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 ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00217516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 8, 2012)	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 ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer
Official Title ICMJE	Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study
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 Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Drug: selenium Given orally; Other: placebo Given orally
Study Arms	Experimental: Arm I Patients receive oral selenium for 3-6 weeks. Intervention: Drug: selenium; Placebo Comparator: Arm II Patients receive oral placebo for 3-6 weeks. Intervention: Other: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 28, 2010)	18
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	October 2008
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Must have undergone ≥ a sextant biopsy Clinical stage T1a-T2a disease; Gleason score < 8; Prostate-specific antigen < 20 ng/mL PATIENT CHARACTERISTICS: Age; Not specified Performance status; Not specified Life expectancy; More than 5 years Hematopoietic; Not specified Hepatic; Not specified Renal; Not specified Other; No other prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy; Not specified Chemotherapy; Not specified Endocrine therapy; No prior hormonal therapy Radiotherapy; No prior radiotherapy Surgery; Not specified Other; More than 30 days since prior and no concurrent participation in another clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise); No selenium at doses > 50 mcg/day as a dietary supplement, including multivitamin supplements
Sex/Gender	Sexes Eligible for Study: Male
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00217516
Other Study ID Numbers ICMJE	CDR0000441225; P30CA016056 ( U.S. NIH Grant/Contract ); RPCI-I-14603
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Roswell Park Cancer Institute
Study Sponsor ICMJE	Roswell Park Cancer Institute
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Michael R. Kuettel, MD, PhD Roswell Park Cancer Institute
PRS Account	Roswell Park Cancer Institute
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP