Selenium in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Selenium may prevent or slow the growth of prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.

Detailed Description
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OBJECTIVES: To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate. To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer. To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms. To further establish the safety of chronic supplementation with selenium in these patients. OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay. Patients complete urological symptom questionnaires and other questionnaires periodically.

Official Title
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Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: selenium
* Other: placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Biopsy-proven adenocarcinoma of the prostate within the past 48 months Prostate-specific antigen < 50 ng/mL Gleason score < 8 Currently undergoing watchful waiting for prostate cancer No metastatic disease PATIENT CHARACTERISTICS: Life expectancy ≥ 3 years AST and ALT ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 1.5 times ULN Bilirubin ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN No other malignancy within the past 5 years, except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day

Ages Eligible for Study
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Maximum Age: 85 Years

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: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity. | Other: placebo<br>* Given orally<br>|
| Experimental: Arm II<br>Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: selenium<br>* Given orally<br>|
| Experimental: Arm III<br>Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. | Dietary Supplement: selenium<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rise in serum prostate-specific antigen |  |  | 
| Rate of rise in chromogranin A and alkaline phosphatase |  |  | 
| Disease progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to prostate cancer therapy |  |  | 
| Time to metastases |  |  | 
| Symptoms of selenium toxicity |  |  | 

 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, stage III prostate cancer, stage IV prostate cancer