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

Roswell Park Cancer Institute18 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

seleniumDRUG

Given orally

placeboOTHER

Given orally

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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