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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00596011 |
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 |
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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) |
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 |
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1: Active Comparator
Polyphenon E, 200 mg EGCG bid
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Drug: Polyphenon E, 200 mg EGCG bid
Polyphenon E, 200 mg EGCG bid
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2: Placebo Comparator
placebo treatment
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Drug: placebo
placebo
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Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nagi Kumar, PhD | (813) 745 6885 | nagi.kumar@moffitt.org |
Contact: Theresa Crocker, MS | (813) 745-6046 | theresa.crocker@moffitt.org |
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 |
Principal Investigator: | Nagi Kumar, PhD | H. Lee Moffitt Cancer Center |
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 |
PIN polyphenon E EGCG |
Prostatic Intraepithelial Neoplasia Hyperplasia Prostatic Diseases Prostatic Hyperplasia |
Carcinoma in Situ Genital Diseases, Male Neoplasms, Glandular and Epithelial Carcinoma |
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 |