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Completed

NCT Number: NCT00676780

Green Tea Extract and Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Polyphenon E (EGCG)

Drug

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

Other names: Polyphenon E

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center Shreveport

Other

Collaborators

  • Polyphenon Pharma

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 13, 2008
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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