Phase Ib Placebo-Controlled Trial of Diindolylmethane (BR-DIM) in the Study of the Modulation of Intermediate Endpoint Markers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Tissue levels of DIM
研究概览
简要总结
Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Compare neoadjuvant prostatic diindolylmethane (DIM^) concentrations in patients with stage I or II adenocarcinoma of the prostate treated with DIM vs placebo prior to radical prostatectomy.
SECONDARY OBJECTIVES:
I. Compare the ratio of urinary 2-hydroxyestrone:16-hydroxyestrone in patients treated with these regimens.
II. Compare plasma levels of total prostate-specific antigen (PSA) in patients treated with these regimens.
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 low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: diindolylmethane (Drug)
Arm I
Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: therapeutic conventional surgery (Procedure)
Arm I
Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: pharmacological study (Other)
Arm II
Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
干预措施: diindolylmethane (Drug)
Arm II
Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
干预措施: therapeutic conventional surgery (Procedure)
Arm II
Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
干预措施: pharmacological study (Other)
Arm III
Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: placebo (Drug)
Arm III
Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: therapeutic conventional surgery (Procedure)
Arm III
Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: laboratory biomarker analysis (Other)
Arm III
Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
干预措施: pharmacological study (Other)
结局指标
主要结局
Tissue levels of DIM
时间窗: Up to 5 years
The distribution of levels of DIM will be summarized by treatment arm with descriptive statistics. For the primary comparison between the placebo group and the DIM groups combined, tissue levels of DIM will be compared using Student t-test. In the case of violation of normality assumptions, an appropriate transformation of the data such as logarithm will be considered or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison. A dose-response relation will be explored based on the analysis of covariance (ANCOVA).
次要结局
- DIM blood steady-state concentrations(Up to 5 years)
- Tissue measures of messenger RNA of CYPs (CYP1A2, CYP1A1, CYP2B1, CYP3A)(Up to 5 years)
- Total PSA(Up to 5 years)
- Measures of androgen receptor, PSA, Ki-67, caspase 3, and TUNEL(Up to 5 years)
- Urinary 2-hydroxyestrone/16-hydroxyestrone ratio(Up to 5 years)
- Serum testosterone(Up to 5 years)
- IGF1:IGFBP-3 ratio(Up to 5 years)