Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT00596011

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

97

Starts

2007-11-14

Expected to finish

2018-07-27

Last updated by the study team

2019-10-04

Who can join

Age: 30 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men with a diagnosis of HGPIN or ASAP in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry. Diagnosis of HGPIN or ASAP (which includes men with ASAP and HGPIN) via trans-rectal ultrasound (TRUS biopsy) is also considered acceptable for inclusion.
• Prostate biopsy with a minimum of 8 cores performed within 6 months of study entry that shows no evidence of cancer.
• 30-80 years of age at the time of registration
• PSA ≤10 ng/ml
• Omnivorous diet
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Participants must have normal organ and marrow function as demonstrated by the following parameters being within normal institutional limits: complete blood count (CBC); liver function tests (LFTs); albumin, total and direct bilirubin, alkaline phosphatase, aspartic transaminase (AST), alanine transaminase (ALT), and total protein), PT/PTT, and LDH; serum creatinine <1.5 mg/dl or measured creatinine clearance 60 cc/min
• 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 containing green tea or green tea polyphenols
• No or low regular tea consumption (no more than 3 servings of hot tea or 6 servings of iced tea per week)
• 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

You may not qualify if…

• Evidence of acute prostatitis or urinary tract infection at the time of PSA measurement; men may be enrolled 30 days after completion of treatment, provided all other eligibility criteria are met
• 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 5 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
• History of medical conditions that may predispose the participant to gastrointestinal bleeding (acute or chronic gastritis or colitis, or acute diverticulitis or hemorrhoids)
• Members of all races and ethnic groups are eligible for this trial. Since this is an investigation targeting men with HGPIN or ASAP, women are not eligible for the study.

Where it is running

• University of Florida/Shands-Department of Urology — Gainesville, Florida, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Watson Clinic Center for Research, Inc. — Lakeland, Florida, United States
• H Lee Moffitt Cancer Center — Tampa, Florida, United States
• James A Haley VA — Tampa, Florida, United States
• University of Chicago - Department of Surgery — Chicago, Illinois, United States
• Overton Brooks VA Medical Center — Shreveport, Louisiana, United States
• LSU Health Sciences Center, Feist-Weiller Cancer Center — Shreveport, Louisiana, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Jefferson Medical College - Department of Urology — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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