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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | 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 atypical small acinar proliferation (ASAP) 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 participants. Participants 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. Participants must meet all inclusion criteria and remain compliant during the run-in period to be randomized to a treatment arm. Participant will complete a quality of life (QOL) survey and have blood collected for baseline tests. Participants will be equally randomized (n=136 per arm) to blinded treatment with either Polyphenon E 200 mg epigallocatechin gallate (EGCG) twice a day (bid) or matching placebo. The planned intervention period is 12 months; participants will return for monthly clinic visits during the intervention period. After 3 and 6 months of intervention, blood will be drawn for serum chemistry and hematology, and other and lower urinary tract symptom (LUTS) and QOL assessments will be performed. In addition, at the 6 month visit, two-day diet recall forms will be collected, blood and urine will be collected, and repeat digital rectal exam (DRE) and prostatic 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. 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 participants in the treatment vs. placebo arm; in addition, the prevalence of HGPIN or ASAP in pre-treatment and post-treatment biopsies in participants treated with Polyphenon E vs. placebo will be compared. If participants 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 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
|---|---|
|
Active Comparator: Polyphenon E Treatment
Polyphenon E, 200 mg EGCG bid
|
Drug: Polyphenon E
Polyphenon E, 200 mg EGCG bid
|
|
Placebo Comparator: Placebo Administration
matching placebo
|
Drug: placebo
matching placebo
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| University of Florida/Shands-Department of Urology | Terminated |
| Gainesville, Florida, United States, 32610 | |
| University of Florida - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Contact: Bryan Schurfranz 904-244-7405 bryan.schurfranz@jax.ufl.edu | |
| Principal Investigator: Christopher Williams, M.D. | |
| Watson Clinic Center for Research, Inc. | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| Contact: Susan Collins, RN 863-603-4722 scollins@watsonclinic.com | |
| Principal Investigator: Fred Schreiber, III, M.D. | |
| Sub-Investigator: Franco Luis, M.D. | |
| Sub-Investigator: Shalini Mulaparthi, M.D. | |
| Sub-Investigator: Antonio Trindade, M.D. | |
| Sub-Investigator: Kamal Haider, M.D. | |
| Sub-Investigator: Karim Anwar, M.D. | |
| Sub-Investigator: Galina Vugman, M.D. | |
| H Lee Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Theresa Crocker 813-745-6046 theresa.crocker@moffitt.org | |
| Principal Investigator: Nagi Kumar, PhD | |
| Sub-Investigator: Julio Pow-Sang, MD | |
| Sub-Investigator: Wade Sexton, MD | |
| Sub-Investigator: Shohrehi Dickinson, M.D. | |
| Sub-Investigator: Domenico Coppola, M.D. | |
| Sub-Investigator: Phillippe Spiess, M.D. | |
| James A Haley VA | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Jaswantrai Trivedi 813-972-2000 jaswantria.trivedi@med.va.gov | |
| Principal Investigator: Raoul Salup, MD | |
| United States, Illinois | |
| University of Chicago - Department of Surgery | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Cheryl Landini 773-702-0792 clandini@surgery.bsd.uchicago.edu | |
| Principal Investigator: Gregory Zagaja, MD | |
| Sub-Investigator: Gregory Bales, M.D. | |
| Sub-Investigator: Scott Eggener, M.D. | |
| Sub-Investigator: Glenn Gerber, M.D. | |
| Sub-Investigator: Arieh Shalhav, M.D. | |
| Sub-Investigator: Norm Smith, M.D. | |
| Sub-Investigator: Jerome Taxy, M.D. | |
| Sub-Investigator: Gregory Zagaja, M.D. | |
| United States, Louisiana | |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Recruiting |
| Shreveport, Louisiana, United States, 71130 | |
| Contact: Ryan Wilkerson 318-675-5655 rwilke@lsuhsc.edu | |
| Principal Investigator: Jerry McLarty, Ph.D. | |
| Sub-Investigator: Donald Elmajian, M.D. | |
| Overton Brooks VA Medical Center | Recruiting |
| Shreveport, Louisiana, United States, 71101-4295 | |
| Contact: Jared Davis 318-990-5560 jared.davis@va.gov | |
| Principal Investigator: Tajammul Fazili, M.D. | |
| United States, Minnesota | |
| Minneapolis VA Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Lori Sorensen 612-629-7215 lori.sorensen@va.gov | |
| Principal Investigator: James Anderson, M.D. | |
| Sub-Investigator: Eduardo Fernandes, M.D. | |
| Sub-Investigator: Steven Schwartz, M.D. | |
| Sub-Investigator: Joel Slaton, M.D. | |
| United States, Pennsylvania | |
| Jefferson Medical College - Department of Urology | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Christine Hubert 215-955-9954 christine.hubert@jefferson.edu | |
| Principal Investigator: Edouard Trabulsi, MD | |
| Sub-Investigator: Deborah Glassman, M.D. | |
| Sub-Investigator: Perry Weiner, D.O. | |
| Principal Investigator: | Nagi Kumar, PhD | H. Lee Moffitt Cancer Center |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00596011 History of Changes |
| Other Study ID Numbers: | MCC-15008, R01 CA12060-01A1 |
| Study First Received: | January 7, 2008 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
PIN polyphenon E EGCG |
|
Prostatic Hyperplasia Hyperplasia Prostatic Intraepithelial Neoplasia Carcinoma in Situ Prostatic Diseases Genital Diseases, Male |
Pathologic Processes Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |