Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 23
- 主要终点
- Determine the ability of flutamide to reduce the incidence of prostate cancer
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.
详细描述
OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality of life of these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0 versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and family history (prostate cancer in brother, father, or uncle versus no prostate cancer in these relatives). Patients are randomized to one of two treatment arms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 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
flutamide
Patients receive oral flutamide once daily.
Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then annually therafter. Patients are followed annually for up to 10 years.
干预措施: flutamide (Drug)
placebo
Patients receive an oral placebo once daily.
Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then annually therafter. Patients are followed annually for up to 10 years.
干预措施: placebo (Other)
结局指标
主要结局
Determine the ability of flutamide to reduce the incidence of prostate cancer
时间窗: Up to 10 years
次要结局
- Overall survival(Up to 10 years)
- Assess the quality of life of these patients(Up to 10 years)