Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
Status:
Completed
Trial end date:
2018-07-27
Target enrollment:
Participant gender:
Summary
The purpose of this study was to determine whether the daily consumption of decaffeinated
green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate
cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120
men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of
standardized green tea extract called Polyphenon E or placebo for a 12-month period and see
if it can prevent progression of the prostate condition to prostate cancer. Investigators
wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken
safely over one year. Investigators wanted to study how Polyphenon E is able to slow the
progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and
the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in
our study, this will be a safe way of treating men who are at high risk or men like you who
have a prostate condition that increases your chances of getting prostate cancer, so that we
can prevent prostate cancer in the future.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute