Green Tea Extract and Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

Detailed Description
-----------------
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

Official Title
-----------------
Green Tea Extract and Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Polyphenon E (EGCG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECGC Extract<br>Single arm for a phase II study | Drug: Polyphenon E (EGCG)<br>* 4 capsules daily with a meal for the duration of the study<br>* Other names: Polyphenon E;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer | Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment. | Baseline and 6 weeks | 
| Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer. | Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment. | Baseline and 6 weeks. | 
| Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer. | Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment. | Baseline and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGCG, polyphenols, biomarkers, prostate specific antigen