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

This study is currently recruiting participants.
Verified by H. Lee Moffitt Cancer Center and Research Institute, January 2008

Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00596011
  Purpose

The clinical study is a Phase II, randomized, double-blinded, placebo-controlled trial in men 30-80 years of age with biopsy proven HGPIN and no evidence of prostate cancer, prostatitis or urinary tract infection. A total of 272 men will be randomized to the study, with the goal of completing 240 evaluable subjects. Subjects who consent to the study and meet initial eligibility criteria will be undergo a one-week run-in period during which they will be asked to self-administer the supplement daily as well as complete study logs and two-day diet recall forms. Subjects must meet all inclusion criteria and remain compliant during the run-in period to be randomized to a treatment arm. Subject will complete a quality of life survey and have blood collected for baseline tests. Subjects will be equally randomized (n=136 per arm) to blinded treatment with either Polyphenon E 200 mg EGCG bid or matching placebo. The planned intervention period is 12 months; subjects will return for monthly clinic visits during the intervention period. After three and six months of intervention, blood will be drawn for serum chemistry and hematology, and other and LUTS and QOL assessments will be performed. In addition, at the six month visit, two-day diet recall forms will be collected, blood and urine will be collected, and repeat DRE and PSA will be performed. If there is a palpable prostate nodule or confirmed PSA increase (>0.75 ng/ml) at six months, a repeat biopsy will be performed. At the end of intervention (maximum of 12 months), a repeat prostate biopsy will be performed for post-intervention endpoint measurements. The primary endpoint of the study is a comparison of the incidence of prostate cancer between subjects in the treatment vs. placebo arm; in addition, the prevalence of HGPIN in pre-treatment and post-treatment biopsies in subjects treated with Polyphenon E vs. placebo will be compared. If subjects develop prostate cancer during the course of the study, the extent and grade of cancer will be assessed and compared between treatment groups.


Condition Intervention Phase
Prostatic Hyperplasia
Drug: Polyphenon E, 200 mg EGCG bid
Drug: placebo
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Phase II, Randomized, Double-Blind, Multi-Centered Study of Polyphenon E in Men With High-Grade Prostatic Intraepithelial Neoplasia (HGPIN)

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • rate of progression to prostate cancer at one year in men treated with Polyphenon E (200 mg EGCG bid) following diagnosis of HGPIN. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the effect of Polyphenon E treatment on quality of life in men diagnosed with HGPIN. Evaluate the effect of Polyphenon E treatment on LUTS and QOL in men diagnosed with HGPIN. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the effect of Polyphenon E treatment on levels of ABCA5 in urine and PCADM-1 in serum [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   272
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2012
Estimated Primary Completion Date:   December 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Polyphenon E, 200 mg EGCG bid
Drug: Polyphenon E, 200 mg EGCG bid
Polyphenon E, 200 mg EGCG bid
2: Placebo Comparator
placebo treatment
Drug: placebo
placebo

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Men with a diagnosis of HGPIN in a minimum of 1 of 12 cores from a biopsy performed within three months of study entry; the diagnosis of HGPIN must be confirmed by the site pathologist
  • Prostate biopsy with a minimum of 12 cores performed within three months of study entry that shows no evidence of cancer; absence of cancer must be confirmed by the site pathologist
  • 30−80 years of age at the time of registration
  • PSA ≤10 ng/ml
  • Omnivorous diet
  • 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, AST, 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 registration, or dutasteride within 90 days of registration
  • Absence of consumption of any nutritional or herbal supplements, including herbs, green tea polyphenols and high-dose antioxidants
  • No or low regular tea consumption (no more than three (3) servings of hot tea or six (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 prostatitis or urinary tract infection; 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 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596011

Contacts
Contact: Nagi Kumar, PhD     (813) 745 6885     nagi.kumar@moffitt.org    
Contact: Theresa Crocker, MS     (813) 745-6046     theresa.crocker@moffitt.org    

Locations
United States, Florida
H Lee Moffitt Cancer Center     Recruiting
      Tampa, Florida, United States, 33612
      Contact: Nagi Kumar, PhD     813-745-6885     nagi.kumar@moffitt.org    
      Principal Investigator: Nagi Kumar, PhD            
      Sub-Investigator: Julio Pow-Sang, MD            
      Sub-Investigator: Said Sebti, PhD            
      Sub-Investigator: Aslam Kazi, PhD            
      Sub-Investigator: Wade Sexton, MD            
      Sub-Investigator: Gwen Quinn, PhD            
      Sub-Investigator: Kathy Egan, PhD            
James A Haley VA     Recruiting
      Tampa, Florida, United States, 33612
      Contact: Raoul Salup, MD     813-972-7579     Raoul.Salup@med.va.gov    
      Principal Investigator: Raoul Salup, MD            
United States, Illinois
University of Chicago     Recruiting
      Chicago, Illinois, United States, 60637
      Contact: Gregory Zagaja, MD     773-834-4830     gzagaja@surgery.bsd.uchicago.edu    
      Principal Investigator: Gregory Zagaja, MD            
United States, Pennsylvania
Jefferson Medical College     Recruiting
      Philadelphia, Pennsylvania, United States, 19107
      Contact: Raffaele Baffa, MD     215-955-9072     R_Baffa@mail.jci.tju.edu    
      Principal Investigator: Raffaele Baffa, MD            

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Nagi Kumar, PhD     H. Lee Moffitt Cancer Center    
  More Information


Responsible Party:   H. Lee Moffitt Cancer Center ( Nagi Kumar, PhD, RD, FADA )
Study ID Numbers:   MCC 15008, USF#105730
First Received:   January 7, 2008
Last Updated:   January 7, 2008
ClinicalTrials.gov Identifier:   NCT00596011
Health Authority:   United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
PIN  
polyphenon E  
EGCG  

Study placed in the following topic categories:
Prostatic Intraepithelial Neoplasia
Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Carcinoma in Situ
Genital Diseases, Male
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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