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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, July 2009
First Received: January 7, 2008   Last Updated: July 31, 2009   History of Changes
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 or ASAP (atypical small acinar proliferation)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 or ASAP 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

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)or Atypical Small Acinar Proliferation (ASAP)

Resource links provided by NLM:


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 or ASAP. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the effect of Polyphenon E treatment on quality of life in men diagnosed with HGPIN or ASAP. Evaluate the effect of Polyphenon E treatment on LUTS and QOL in men diagnosed with HGPIN or ASAP. [ 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

  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 or ASAP in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry.
  • Prostate biopsy with a minimum of 8 cores performed within six 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
  • 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: Shang-Tian Chuang, D.O.            
Sub-Investigator: Domenico Coppola, M.D.            
Sub-Investigator: Phillippe Spiess, M.D.            
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            
University of Florida/Shands-Department of Urology Recruiting
Gainesville, Florida, United States, 32610
Contact: Charles Rosser, M.D.     352-273-6815     Charles.Rosser@urology.ufl.edu    
Principal Investigator: Charles Rosser, M.D.            
United States, Illinois
University of Chicago - Department of Surgery 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, Louisiana
LSU Health Sciences Center, Feist-Weiller Cancer Center Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Jerry McLarty, Ph.D.     813-675-8776     jmclar@lsuhsc.edu    
Principal Investigator: Jerry McLarty, Ph.D.            
United States, Pennsylvania
Jefferson Medical College - Department of Urology Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Raffaele Baffa, MD     215-955-9072     R_Baffa@mail.jci.tju.edu    
Principal Investigator: Edouard Trabulsi, MD            
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Nagi Kumar, PhD H. Lee Moffitt Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center ( Nagi Kumar, PhD, RD, FADA )
Study ID Numbers: MCC 15008, USF#105730, RO1 CA12060-01A1
Study First Received: January 7, 2008
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00596011     History of Changes
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:
Prostatic Intraepithelial Neoplasia
Neoplasms
Hyperplasia
Neoplasms by Histologic Type
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Carcinoma in Situ
Genital Diseases, Male
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009