Prostate Cancer Clinical Trial
Official title:
Green Tea Extract and Prostate Cancer
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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