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Green Tea Extract and Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00676780
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Collaborator:
Polyphenon Pharma
Information provided by (Responsible Party):
Jerry McLarty, Louisiana State University Health Sciences Center Shreveport

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Polyphenon E (EGCG) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Green Tea Extract and Prostate Cancer
Study Start Date : May 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: Polyphenon E


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676780


Locations
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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
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Principal Investigator: Jerry W McLarty, Ph.D. LSUHSC Shreveport
More Information
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Publications of Results:

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Responsible Party: Jerry McLarty, Professor, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676780    
Other Study ID Numbers: H04-176
First Posted: May 13, 2008    Key Record Dates
Results First Posted: August 8, 2012
Last Update Posted: August 8, 2012
Last Verified: June 2012
Keywords provided by Jerry McLarty, Louisiana State University Health Sciences Center Shreveport:
EGCG
polyphenols
biomarkers
prostate specific antigen
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases