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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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Prostate Cancer
Intervention Drug: Polyphenon E (EGCG)
Enrollment 33
Recruitment Details Patients were recruited from the urology clinic at LSU Health, Shreveport during the period of May 1, 2004 and February 20, 2008.
Pre-assignment Details Exclusion criterias were determined before enrollment process.
Arm/Group Title ECGC Extract, Prostate Cancer
Hide Arm/Group Description Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Period Title: Overall Study
Started 33
Completed 26
Not Completed 7
Arm/Group Title ECGC Extract, Prostate Cancer
Hide Arm/Group Description Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  81.8%
>=65 years
6
  18.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
58.6  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
0
   0.0%
Male
33
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer
Hide Description Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined per protocol.
Arm/Group Title ECGC Extract
Hide Arm/Group Description:
Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
Overall Number of Participants Analyzed 26
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.86
(0.0425 to 2.4675)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ECGC Extract
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.027
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.
Hide Description Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.
Time Frame Baseline and 6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined per protocol.
Arm/Group Title ECGC Extract
Hide Arm/Group Description:
Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
Overall Number of Participants Analyzed 26
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
26.8
(-6.315 to 123.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ECGC Extract
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.
Hide Description Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for analysis was determined per protocol.
Arm/Group Title ECGC Extract
Hide Arm/Group Description:
Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
Overall Number of Participants Analyzed 26
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
96.67
(27.0837 to 358.7475)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ECGC Extract
Comments Null hypothesis is no change, i.e. median change = 0.0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ECGC Extract, Prostate Cancer
Hide Arm/Group Description Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
All-Cause Mortality
ECGC Extract, Prostate Cancer
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ECGC Extract, Prostate Cancer
Affected / at Risk (%) # Events
Total   1/33 (3.03%)    
Cardiac disorders   
Myocardial Infarction * [1]  1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subject suffered a heart attack prior to surgery procedure. Determined to be not related to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ECGC Extract, Prostate Cancer
Affected / at Risk (%) # Events
Total   0/33 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jerry W. McLarty, Ph.D.
Organization: LSUShreveport
Phone: (318)813-1446
Responsible Party: Jerry McLarty, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT00676780     History of Changes
Other Study ID Numbers: H04-176
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: August 29, 2011
Results First Posted: August 8, 2012
Last Update Posted: August 8, 2012