Green Tea Extract and Prostate Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
Full 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
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
33 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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