Green Tea Extract and Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Polyphenon E (EGCG)

Registration Number: NCT00676780

Lead Sponsor: Louisiana State University Health Sciences Center Shreveport

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 33

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECGC Extract	Polyphenon E (EGCG)	Single arm for a phase II study

Primary Outcome Measures

Name	Time	Method
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer	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.	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.	Baseline and 6 weeks	Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.