Clinical trial NCT00676780: Green Tea Extract and Prostate Cancer
Official title: Green Tea Extract and Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: EGCG
polyphenols
biomarkers
prostate specific antigen
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Polyphenon Pharma
First posted: 2008-05-13
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 criteria: 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)

Primary outcomes:
measure: Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
timeFrame: Baseline and 6 weeks
measure: Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
timeFrame: Baseline and 6 weeks.
measure: Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
affiliation: LSUHSC Shreveport
name: Jerry W McLarty, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.