Green Tea Extract and Prostate Cancer

June 29, 2012 updated by: Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECGC Extract
Single arm for a phase II study
Drug: Polyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study
Other Names:
  • Polyphenon E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Time Frame: Baseline and 6 weeks
Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Baseline and 6 weeks
Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Time Frame: Baseline and 6 weeks.
Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Baseline and 6 weeks.
Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Time Frame: Baseline and 6 weeks
Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center Shreveport

Collaborators

Polyphenon Pharma

Investigators

  • Principal Investigator: Jerry W McLarty, Ph.D., LSUHSC Shreveport

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H04-176

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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