Spots Global Cancer Trial Database for Green Tea Extract and Prostate Cancer
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Trial Identification
Brief Title: Green Tea Extract and Prostate Cancer
Official Title: Green Tea Extract and Prostate Cancer
Study ID: NCT00676780
Conditions
Interventions
Study Description
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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
LSU Health Sciences Center, Shreveport, Louisiana, United States
Contact Details
Name: Jerry W McLarty, Ph.D.
Affiliation: LSUHSC Shreveport
Role: PRINCIPAL_INVESTIGATOR
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