Green Tea Extract and Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Polyphenon Pharma
Information provided by (Responsible Party):
Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT00676780
First received: May 9, 2008
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.


Condition Intervention Phase
Prostate Cancer
Drug: Polyphenon E (EGCG)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Green Tea Extract and Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.


Enrollment: 33
Study Start Date: May 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Polyphenon E

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676780

Locations
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Polyphenon Pharma
Investigators
Principal Investigator: Jerry W McLarty, Ph.D. LSUHSC Shreveport
  More Information

Publications:
Responsible Party: Jerry McLarty, Professor, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676780     History of Changes
Other Study ID Numbers: H04-176
Study First Received: May 9, 2008
Results First Received: August 29, 2011
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
EGCG
polyphenols
biomarkers
prostate specific antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014