Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-treatment green tea catechin concentration levels in prostate tissue
研究概览
简要总结
Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
详细描述
PRIMARY OBJECTIVES:
I. Determine the bioavailability of defined green tea catechin extract in prostate tissue after treatment with defined green tea extract in patients with prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the effect of this treatment on changes in clusterin levels and matrix metalloproteinase (MMP)-2 and MMP-9 in prostate tissue from these patients.
II. Determine the effect of this treatment on changes in serum insulin-like growth factor (IGF)-1 and IGF binding protein-3 in 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
- Prevention
- 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 (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: defined green tea catechin extract (Dietary Supplement)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: immunohistochemistry staining method (Other)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: immunoenzyme technique (Other)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: laboratory biomarker analysis (Other)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: biopsy (Procedure)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: mass spectrometry (Other)
Arm I (green tea catechin extract)
Patients receive oral defined green tea catechin extract daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: high performance liquid chromatography (Other)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: placebo (Drug)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: immunohistochemistry staining method (Other)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: immunoenzyme technique (Other)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: biopsy (Procedure)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: mass spectrometry (Other)
Arm II (placebo)
Patients receive oral placebo daily for 4-7 weeks.
All patients undergo surgery one day after the last dose of study agent.
干预措施: high performance liquid chromatography (Other)
结局指标
主要结局
Post-treatment green tea catechin concentration levels in prostate tissue
时间窗: Up to 6 weeks
Descriptive statistics will be performed on prostate tissue EGCG within each intervention group. The difference in concentration levels between the two intervention groups will be tested using a two-group t-test at a one-sided 0.05 level of significance. If the distributions are not symmetrical, a non-parametric Wilcoxon test will be considered. The percentage of patients positive for EGCG in prostate tissue will be compared between the intervention groups using a Fisher's exact test of proportions at a one-sided 0.05 level of significance.
次要结局
- Change in ratio of 8OHdG:dG(Baseline to post-treatment)
- Changes in clusterin, matrix metalloproteinase (MMP)-2, and MMP-9 levels(Baseline to post-treatment)
- Changes in Serum levels of insulin-like growth factor (IGF)-1 and IGF binding protein-3(Baseline to post-treatment)
- Change in plasma levels of EGCG(Baseline to post-treatment)