Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Mean Level of Diindolylmethane in Prostate Tissue After Treatment
研究概览
简要总结
RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow the growth of tumor cells.
PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients with stage I or stage II prostate cancer undergoing radical prostatectomy.
详细描述
OBJECTIVES:
Primary
- To measure the level of diindolylmethane in prostate tissue after treatment with oral microencapsulated diindolylmethane (B-DIM) in patients with stage I or II adenocarcinoma of the prostate undergoing radical prostatectomy.
Secondary
- To measure serum biomarkers (e.g., total PSA, serum testosterone, and diindolylmethane levels) pre- and post-treatment with B-DIM.
- To measure tissue biomarkers (e.g., androgen receptor, NF-κB, and PSA) pre- and post-treatment with B-DIM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 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
B-Dim, Radical Prosatectomy
B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
干预措施: B-Dim (Drug)
B-Dim, Radical Prosatectomy
B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Radical Prostatectomy
干预措施: Radical Prosatectomy (Procedure)
结局指标
主要结局
Mean Level of Diindolylmethane in Prostate Tissue After Treatment
时间窗: Within the first 24 months after radical prostatectomy.
次要结局
- Serum Levels of PSA, Testosterone, and Diindolylmethane(Pre and post radical prostatectomy)
- Levels of Androgen Receptor in Prostate Tissue(Pre and post radical prostatectomy)
研究者
Elisabeth Heath
Principal Investigator
Barbara Ann Karmanos Cancer Institute