Green Tea Extract and Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Green Tea Extract and Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676780
• Other study ID #: H04-176
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2008
• Last updated: June 29, 2012
• Start date: May 2004
• Est. completion date: December 2008

Study information

• Verified date: June 2012
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Polyphenon E (EGCG)
4 capsules daily with a meal for the duration of the study

Locations

Country	Name	City	State
United States	LSU Health Sciences Center	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport	Polyphenon Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 he — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer	Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.	Baseline and 6 weeks	No
Primary	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.	Baseline and 6 weeks.	No
Primary	Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.	Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.	Baseline and 6 weeks	No