Clinical Trial Details

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Study ID NCI-2009-00894
Investigator
Frederick Ahmann,   Arizona Cancer Center - Tucson
Title Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
Conditions Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Interventions Dietary Supplement: defined green tea catechin extract
Drug: placebo
Other: immunohistochemistry staining method
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: biopsy
Other: mass spectrometry
Other: high performance liquid chromatography
Phase Phase 1
Purpose Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Criteria:
  • Biopsy-proven adenocarcinoma of the prostate meeting the following criteria: organ-confined disease; treatable by prostatectomy
  • PSA < 50 ng/mL
  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
  • Bilirubin normal
  • AST and ALT normal
  • Creatinine normal
  • Fertile patients must use effective contraception
  • No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract
  • No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery)
  • No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment)
  • No regular tea consumption (> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month
  • No other concurrent investigational agents
  • No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea
  • Study Location
    Arizona Cancer Center - Tucson
    Tucson, Arizona, 85724-5024
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 9/18/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00459407


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