Expired Study
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Buffalo, New York 14263


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.


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



Primary Contact:

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

Backup Contact:


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

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