Green Tea Extract and Prostate Cancer
18 Years
75 Years
Male
Prostate Cancer
Trial Information
Green Tea Extract and Prostate Cancer
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
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Outcome Description:
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Outcome Time Frame:
Baseline and 6 weeks
Safety Issue:
No
Principal Investigator
Jerry W McLarty, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
LSUHSC Shreveport
Authority:
United States: Food and Drug Administration
Study ID:
H04-176
NCT ID:
NCT00676780
Start Date:
May 2004
Completion Date:
December 2008
Related Keywords:
- Prostate Cancer
- EGCG
- polyphenols
- biomarkers
- prostate specific antigen
- Prostatic Neoplasms
Name | Location |
|---|---|
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
