Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Intraepithelial Neoplasia; Prostatic Hyperplasia; Hyperplasia
Intervention: Polyphenon E; Placebo
Intervention description: Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.; Matching placebo BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: Male
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: prostate cancer; PIN; polyphenon E; EGCG

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.