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

PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

November 14, 2007

Primary Completion Date

March 25, 2014

Study Completion Date

July 27, 2018

Conditions
Prostatic Hyperplasia
Interventions
DRUG

Polyphenon E

Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.

DRUG

Placebo

Matching placebo BID

Trial Locations (10)

19107

Jefferson Medical College - Department of Urology, Philadelphia

32209

University of Florida - Jacksonville, Jacksonville

32610

University of Florida/Shands-Department of Urology, Gainesville

33612

H Lee Moffitt Cancer Center, Tampa

James A Haley VA, Tampa

33805

Watson Clinic Center for Research, Inc., Lakeland

55417

Minneapolis VA Medical Center, Minneapolis

60637

University of Chicago - Department of Surgery, Chicago

71130

LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport

71101-4295

Overton Brooks VA Medical Center, Shreveport

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00596011 - Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia | Biotech Hunter | Biotech Hunter