Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2004-05-31
2008-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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ECGC Extract
Single arm for a phase II study
Polyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study
Interventions
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Polyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
MALE
No
Sponsors
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Polyphenon Pharma
UNKNOWN
Louisiana State University Health Sciences Center Shreveport
OTHER
Responsible Party
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Jerry McLarty
Professor
Principal Investigators
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Jerry W McLarty, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
LSUHSC Shreveport
Locations
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LSU Health Sciences Center
Shreveport, Louisiana, United States
Countries
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References
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McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res (Phila). 2009 Jul;2(7):673-82. doi: 10.1158/1940-6207.CAPR-08-0167. Epub 2009 Jun 19.
Other Identifiers
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H04-176
Identifier Type: -
Identifier Source: org_study_id