Green Tea Extract and Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polyphenon E (EGCG)
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring EGCG, polyphenols, biomarkers, prostate specific antigen
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)
Sites / Locations
- LSU Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECGC Extract
Arm Description
Single arm for a phase II study
Outcomes
Primary Outcome Measures
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT00676780
First Posted
May 9, 2008
Last Updated
June 29, 2012
Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Polyphenon Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00676780
Brief Title
Green Tea Extract and Prostate Cancer
Official Title
Green Tea Extract and Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Polyphenon Pharma
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
EGCG, polyphenols, biomarkers, prostate specific antigen
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECGC Extract
Arm Type
Experimental
Arm Description
Single arm for a phase II study
Intervention Type
Drug
Intervention Name(s)
Polyphenon E (EGCG)
Other Intervention Name(s)
Polyphenon E
Intervention Description
4 capsules daily with a meal for the duration of the study
Primary Outcome Measure Information:
Title
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Description
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Time Frame
Baseline and 6 weeks
Title
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Description
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Time Frame
Baseline and 6 weeks.
Title
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Description
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry W McLarty, Ph.D.
Organizational Affiliation
LSUHSC Shreveport
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19542190
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.
Results Reference
result
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Green Tea Extract and Prostate Cancer
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