Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in preventing the development of prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E, selenium, and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia.

Detailed Description
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OBJECTIVES: Determine whether nutritional supplementation with soy protein isolate, vitamin E, and selenium can delay the time to development of invasive prostate cancer (disease-free survival) in patients with high-grade prostatic intraepithelial neoplasia. Determine the effect of this supplementation on intermediate endpoints that may reflect a lessened risk of invasive prostate cancer (e.g., serum PSA levels, hormone levels, lycopene, malondialdehyde, vitamin E, and reduced thiol groups) in these patients. Determine the safety of this supplementation in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral vitamin E, oral selenium, and oral soy protein isolate twice daily. Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 3 years in the absence of invasive prostate cancer (demonstrated on biopsy) or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 306 patients (153 per treatment arm) will be accrued for this study within 6 years.

Official Title
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A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia

Conditions
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Precancerous/Nonmalignant Condition, Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: selenium
* Dietary Supplement: soy protein isolate
* Dietary Supplement: vitamin E


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN) No evidence of invasive prostate cancer by at least 2 biopsies within the past 18 months At least 1 biopsy must show evidence of HGPIN within the past 6 months No prior invasive prostate cancer PATIENT CHARACTERISTICS: Age Not specified Performance status Not specified Life expectancy More than 5 years Hematopoietic Platelet count at least 75,000/mm^3 No coagulopathies Hepatic Bilirubin no greater than 2 times upper limit of normal (ULN) PT (INR) no greater than 1.5 times ULN PTT no greater than 1.5 times ULN No hepatic insufficiencies Renal Creatinine no greater than 2 times ULN No renal insufficiencies Other No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma) No other malignancy within the past 5 years except superficial bladder cancer No known bowel malabsorption No dietary behavior (e.g., morbid obesity or eating disorders) that would limit adherence to study therapy No major illness, including psychiatric illness, that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 3 months since prior androgen therapy More than 3 months since prior hormonal therapy for benign prostatic hyperplasia (e.g., finasteride) No concurrent finasteride No concurrent androgen therapy Radiotherapy More than 2 years since prior radiotherapy to the pelvic region Surgery Not specified Other More than 2 weeks since prior supplemental vitamin E or selenium No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein isolate (more than 2 servings/week) No other concurrent treatment for high-grade prostatic intraepithelial neoplasia

Ages Eligible for Study
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Maximum Age: 120 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: Prevention
Allocation: Randomized
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: selenium|nan|
|Dietary Supplement: soy protein isolate|nan|
|Dietary Supplement: vitamin E|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, high grade prostatic intraepithelial neoplasia