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Prostate Cancer:
Phase 1b Study of Polyphenon E in Pre-prostatectomy Prostate Cancer Cohort

Who is conducting the study? This National Cancer Institute-funded study will be conducted by Arizona Cancer Center researchers at the University of Arizona.
Principal Investigator: Frederick Ahmann, MD

What is the purpose of the Study?  The purpose of this randomized, placebo-controlled study is to determine whether Polyphenon E (a defined green tea extract) can affect biomarkers in blood and/or prostate tissue in men with prostate cancer

What is the treatment?  Study participants are randomized into one of two different groups, taking capsules of a green tea extract or a placebo (no active ingredients) daily for three to six weeks before prostate cancer surgery.

How long is the study? To participate, patients are asked to devote a 6 week time period to the study.

Who is eligible for the study? 

Participants must meet the following criteria for inclusion:

• Biopsy proven adenocarcinoma of the prostate
• Scheduled for prostatectomy in 4-6 weeks
  
• Not already treated with hormone therapy, XRT, or surgery
• Not known to have metastatic disease
• No chemo or XRT for other malignancy in the past 5 years
• Normal liver and kidney function
• Able to understand written informed consent in English

Participants will be excluded for the following criteria:

• Uncontrolled intercurrent illness
• Receiving other investigation agents
• Tea drinkers who consume in the average month:
  • More than 6 servings of hot tea (per week)
  • More than 12 servings of iced tea (per week)

What is required during the study? Participants must attend two study visits – one for consenting and baseline blood draw; second for pre-op research blood samples and compliance measures.
At study entry, subjects will be randomized to 4-6 weeks of Polyphenon E or matched placebo (4 capsules QD: Polyphenon E dose equivalent to 8-16 cups of green tea). Dosing will continue until the pre-operative day.
Participants will be expected to give samples for study endpoints:

• Blood (for tea catechin measurement, IGF-1, IGFBP-3, 8OHdG)
• Frozen prostate tissue from prostatectomy (for tea catechin measurement)
• Paraffin-embedded prostate tissue (for clusterin, MMP-2, MMP-9) from diagnostic biopsy and prostatectomy

Subjects will be compensated for their participation. For more information, please contact:

Frances Minter Epstein
(520) 321-7798 ext 25

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