A Randomized, Double Blind, Placebo Controlled Clinical Trial of L-SeMet Supplementation and Finasteride Treatment of Patients With Prostate Cancer Prior to Robotic Prostatectomy/Brachytherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Effects of Selenium and Finasteride and Their Combination on PSA Level
研究概览
简要总结
RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving selenomethionine together with finasteride before surgery or radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride work when given before surgery or radiation therapy in treating patients with stage I or stage II prostate cancer.
详细描述
OBJECTIVES:
Primary
- To investigate the effects of selenomethionine and/or finasteride on key androgen receptor signaling biomarkers (prostate-specific antigen, kallikrein 2, and NKX3.1) in prostate tissue samples from patients with stage I or II prostate cancer.
Secondary
- To analyze the effects of selenomethionine and/or finasteride on apoptosis induction in benign prostate tissue samples from these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
Arm I
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
干预措施: selenomethionine (Dietary Supplement)
Arm I
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
干预措施: finasteride (Drug)
Arm II
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
干预措施: finasteride (Drug)
Arm II
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
干预措施: placebo (Other)
Arm III
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
干预措施: selenomethionine (Dietary Supplement)
Arm III
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
干预措施: placebo (Other)
Arm IV
Patients receive two oral placebos once daily for 4-5 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Effects of Selenium and Finasteride and Their Combination on PSA Level
时间窗: 1 year
Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.
次要结局
- Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction(1 year)