Official Title

Green Tea Extract and Prostate Cancer
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    green tea ...
  • Study Participants

    33
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
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 Started
May 31
2004
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Results Posted
Aug 08
2012
Estimate
Last Update
Aug 08
2012
Estimate

Drug Polyphenon E (EGCG)

4 capsules daily with a meal for the duration of the study

  • Other names: Polyphenon E

ECGC Extract Experimental

Single arm for a phase II study

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)

Summary

ECGC Extract, Prostate Cancer

All Events

Event Type Organ System Event Term ECGC Extract, Prostate Cancer

Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer

Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.

ECGC Extract

0.86
ng/mL (Median)
Inter-Quartile Range: 0.0425 to 2.4675

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.

ECGC Extract

26.8
pg/mL (Median)
Inter-Quartile Range: -6.315 to 123.38

Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.

Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.

ECGC Extract

96.67
pg/mL (Median)
Inter-Quartile Range: 27.0837 to 358.7475

Age Continuous

58.6
years (Mean)
Standard Deviation: 7.1

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

ECGC Extract, Prostate Cancer