NCT00064194已完成3 期
A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •More than 5 years
- •Hematopoietic
- •Platelet count at least 75,000/mm^3
- •No coagulopathies
- •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
- •Creatinine no greater than 2 times ULN
- •No renal insufficiencies
- •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
- •Not specified
- •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
排除标准
- 未提供
研究者
研究点 (3)
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