Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Intraepithelial Neoplasia; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      At the baseline/randomization visit, a QOL (Medical Outcomes Study Short Form-36) and lower
      urinary tract symptoms (LUTS) score assessment will be completed; urine and serum will be
      collected for measurement of diagnostic markers; plasma will be collected for measurement of
      baseline catechin levels; serum will be collected for banking; and diet recall forms will be
      collected. Participants will be equally randomized to blinded treatment with either
      Polyphenon E 200 mg EGCG bid or matching placebo, and an initial supply of study drug will be
      dispensed. All participants will also be provided with a standard multivitamin/mineral
      supplement to assure consistent, appropriate nutrient intake among study participants. The
      planned intervention period is 12 months; participants will return for monthly clinic visits
      during the intervention period. At each monthly clinic visit, blood will be drawn for repeat
      hepatic function panel, lactate dehydrogenase (LDH) and prothrombin time/partial
      thromboplastin time (PT/PTT), and participants will be interviewed to review and capture
      information from study agent intake log (pill count), assess signs and symptoms and
      concomitant medications; additional study medication will be dispensed as needed. After 3 and
      6 months of intervention, blood will be drawn for serum chemistry and hematology, and LUTS
      and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall
      forms will be collected, blood will be drawn for plasma catechin measurements and serum
      banking, serum and urine will be collected for diagnostic marker measurement, and repeat
      digital rectal exam (DRE) and prostate specific antigen (PSA) will be performed. If there is
      a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at 6 months, a repeat
      biopsy will be performed. If the 6-month biopsy shows evidence of disease progression,
      participants will stop intervention and proceed to the post-intervention assessment;
      otherwise, intervention will continue through month 12. At the end of intervention (maximum
      of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint
      measurements. In addition, the physical exam and DRE, LUTS and QOL will be repeated, and
      2-day diet recall forms will be collected. Blood will be drawn for serum chemistry and
      hematology, PSA, hepatic function panel, LDH, PT/PTT; serum and urine will be collected for
      diagnostic marker measurement; plasma will be collected for catechin measurements; and serum
      will be collected for banking. Participants will be interviewed to review and capture
      information from study agent intake log (pill count), assess signs and symptoms and
      concomitant medications.
    

Intervention name(s): Polyphenon E; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): green tea catechins; PolyE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prostate cancer; PIN; polyphenon E; EGCG