Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00217516


Primary Contact:

Principal Investigator
Michael R. Kuettel, MD, PhD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.