Green Tea Extract and Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
研究概览
简要总结
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
详细描述
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.
The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.
1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •recent biopsy positive for prostate cancer
- •scheduled for prostatectomy
- •must be able to swallow capsules
- •Palpable mass by digital rectal examination (DRE)
- •Ability to give informed consent and willingness to adhere to study protocol
- •Age ≥ 18 years and less than 75
排除标准
- •abnormal liver function
- •Prior hormonal or surgical therapy for prostate cancer
- •Liver or kidney problems that would interfere with metabolism of study drug
- •Any condition that would hamper informed consent or ability to comply with study protocol
- •Participation in another research study in the last three months
- •Known malignancy at any site other than prostate
- •Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
研究组 & 干预措施
ECGC Extract
Single arm for a phase II study
干预措施: Polyphenon E (EGCG) (Drug)
结局指标
主要结局
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
时间窗: Baseline and 6 weeks
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
时间窗: Baseline and 6 weeks.
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
时间窗: Baseline and 6 weeks
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
次要结局
未报告次要终点
研究者
Jerry McLarty
Professor
Louisiana State University Health Sciences Center Shreveport