L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 619
- 主要终点
- Presence of Carcinoma of the Prostate as Measured by Biopsy
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.
PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.
详细描述
OBJECTIVES:
- Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
- Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral selenium once daily.
- Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 8 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
L-selenomethionine
L-selenomethionine (Selenium)one tablet by mouth daily for 3 years.
干预措施: L-selenomethionine (Drug)
L-selenomethionine placebo
L-selenomethionine placebo one tablet by mouth daily for 3 years
干预措施: L-selenomethionine placebo (Drug)
结局指标
主要结局
Presence of Carcinoma of the Prostate as Measured by Biopsy
时间窗: 3 years
The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.
次要结局
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(3 months after randomization and then every 3 months for 3 years)