Randomized Placebo-Controlled, Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months
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 eflornithine (DMFO) may be an effective way to prevent the development of prostate cancer.
PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.
详细描述
OBJECTIVES:
- Compare the levels of polyamines (putrescine, spermidine, and spermine) and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine (DFMO) vs placebo.
- Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs no).
All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms.
- Arm I: Patients receive oral placebo daily.
- Arm II: Patients receive high-dose oral eflornithine (DFMO) daily. Treatment continues for 1 year in the absence of unacceptable toxicity.
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
- 35 Years 至 70 Years（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
eflornithine
500mg/d for 12 months
干预措施: eflornithine (Drug)
Placebo
placebo for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months
时间窗: Baseline and 12 months
Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.
次要结局
未报告次要终点
研究者
Thomas E. Ahlering
Professor
University of California, Irvine