NCT00736164撤回2 期
A Randomized, Double Blind, Placebo Controlled Clinical Trial of Supplementation of L-Selenomethionine in Patients With Prostate Cancer Prior to Prostatectomy or Brachytherapy (Se Pre-Prostatectomy/Pre-Brachytherapy Trial)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Quantity of androgen receptor message expression
研究概览
简要总结
RATIONALE: Selenomethionine may slow the growth of prostate cancer. Giving selenomethionine before surgery or internal radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine works in treating patients undergoing surgery or internal radiation therapy for stage I or stage II prostate cancer.
详细描述
OBJECTIVES:
Primary
- To investigate the down-regulation of the androgen receptor using tissue samples from patients with stage I or II prostate cancer treated with selenomethionine for 8-9 weeks prior to undergoing prostatectomy or brachytherapy.
Secondary
- To evaluate the down regulation of a number of genes regulated by the androgen receptor (i.e., prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24) using tissue samples from these patients.
- To evaluate the down-regulation of haptic nuclear factor 3-alpha using tissue samples from these patients.
- To evaluate whether the thiol methyltransferase phenotype modifies the prostatic response to short-term selenomethionine supplementation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
结局指标
主要结局
Quantity of androgen receptor message expression
次要结局
- Expression of prostate-specific antigen, kallikrein 2, cell division cycle 6, and dehydrocholesterol reductase 24
- Expression of haptic nuclear factor 3-alpha
- Variation in thiol methyltransferase phenotype
研究者
相似试验
已完成
2 期
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate CancerProstate CancerNCT00736645Roswell Park Cancer Institute55
已完成
2 期
Selenium in Treating Patients With Prostate CancerProstate CancerNCT00752739University of Arizona220
已完成
3 期
Selenium in Preventing Prostate CancerProstate CancerNCT00978718University of Arizona700
已完成
1 期
Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate CancerProstate CancerNCT00217516Roswell Park Cancer Institute18
终止
2 期
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate CancerProstate CancerNCT00515112University of Chicago6