Study Title: Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men with High-grade Prostatic Intraepithelial Neoplasia (HGPIN)

What is Polyphenon E?
Polyphenon E is a highly purified tea catechin extract, made from 100% green tea leaves. The catechins are extracted with hot water and spray-dried into a fine powder. It is the first pharmaceutical grade green tea catechin in the world. This study utilizes a decaffeinated variety.

Trial Details
Study Description: This multi-center trial will examine the safety and effectiveness of Polyphenon E in preventing Prostate Cancer in Men diagnosed with High-grade Prostatic Intraepithelial Neoplasia (HGPIN).
Study Design:   Phase II, Randomized, Double-blind, Multi-centered Study
Primary Outcome Measures: Safety and Efficacy
Estimated Enrollment:   272
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2013
Study Arms
Subjects participating in the study will be randomized to receive either Polyphenon E (200 mg EGCG bid) or placebo (n=136/arm). All subjects will also be provided with a daily multivitamin/mineral supplement to ensure equivalent intake of essential nutrients. Study drug administration will continue from the time of randomization until the time of repeat biopsy; the planned/maximum duration of treatment is one year.

Major Inclusion Criteria:

Men with a diagnosis of HGPIN in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry. Diagnosis if HGPIN via trans-rectal ultrasound (TRUS biopsy) is also considered acceptable for inclusion.

Prostate biopsy must show no evidence of atypical small acinar proliferation (ASAP) or cancer

30?80 years of age at the time of informed consent

PSA ?10 ng/ml

Omnivorous diet

ECOG performance status 0?2

Participants must have normal organ and marrow function

Absence of consumption of toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements or medications which have known impact on PSA within 30 days of informed consent, or dutasteride within 90 days of informed consent

Absence of consumption of any nutritional or herbal supplements, including herbs, green tea polyphenols and high-dose antioxidants

No or low regular tea consumption

Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study

Willing to use an effective method of contraception, if the partner is of child-bearing age, while on study

Willing to comply with proposed visit and treatment schedule

Able to understand and willing to sign a written informed consent document

Major Exclusion Criteria:

Evidence of acute prostatitis or urinary tract infection at the time of PSA measurement

Current or prior history of prostate cancer or other malignancies (exceptions include non-melanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitive treatment)

History of renal or hepatic disease, including history of hepatitis B, C or delta

Participation in any other investigational study or use of any other investigational agents within 30 days of study entry

History of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to Polyphenon E or the inactive components present in Polyphenon E and placebo capsules

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol