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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Brachytherapy. Selenium Brachytherapy Trial: Phase I/Pilot Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: selenium
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral selenium for 3-6 weeks. | Drug: selenium<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo for 3-6 weeks. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility at 1 and 6 months after completion of study treatment |  | 1 and 6 months after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of selenium on antioxidant enzyme activities at 1 and 6 months after completion of study treatment |  | 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 |  | 1 and 6 months after completion of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer