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CHEMOPREVENTION OF PROSTATE CANCER IN MEN AT HIGH RISK: RATIONALE AND DESIGN OF THE REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS (REDUCE) TRIAL

2004; Lippincott Williams & Wilkins; Volume: 172; Issue: 4 Part 1 Linguagem: Inglês

10.1097/01.ju.0000139320.78673.2a

1527-3792

Gerald L. Andriole, David G. Bostwick, Otis W. Brawley, Leonard G. Gomella, Michael Marberger, Donald J. Tindall, SHARON BREED, Matthew C. Somerville, Roger S. Rittmaster,

Prostate Cancer Treatment and Research

No AccessJournal of UrologyAdult Urology: Oncology: Prostate/Testis/Penis/Urethra1 Oct 2004CHEMOPREVENTION OF PROSTATE CANCER IN MEN AT HIGH RISK: RATIONALE AND DESIGN OF THE REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS (REDUCE) TRIAL GERALD ANDRIOLE, DAVID BOSTWICK, OTIS BRAWLEY, LEONARD GOMELLA, MICHAEL MARBERGER, DONALD TINDALL, SHARON BREED, MATT SOMERVILLE, ROGER RITTMASTER, and REDUCE STUDY GROUP GERALD ANDRIOLEGERALD ANDRIOLE Financial interest and/or other relationship with Abbott Laboratories, Antigenics, Bambridge Scientific, Barr Laboratories, Bion Diagnostic, C. D. Searle, Cell Pathways, GlaxoSmithKline, Merck, Pharmacia and Zeneca. More articles by this author , DAVID BOSTWICKDAVID BOSTWICK Financial interest and/or other relationship with GlaxoSmithKline, Genotherapeutics, DiagnoCure, PhotoCure, AstraZeneca, Bostwick Laboratories, Medlon and Endocare. More articles by this author , OTIS BRAWLEYOTIS BRAWLEY Financial interest and/or other relationship with Theragenics, Merck, GlaxoSmithKline and Sanofi. More articles by this author , LEONARD GOMELLALEONARD GOMELLA Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , MICHAEL MARBERGERMICHAEL MARBERGER Financial interest and/or other relationship with MSD and GlaxoSmithKline. More articles by this author , DONALD TINDALLDONALD TINDALL Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , SHARON BREEDSHARON BREED Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , MATT SOMERVILLEMATT SOMERVILLE Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , ROGER RITTMASTERROGER RITTMASTER Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , and REDUCE STUDY GROUP More articles by this author View All Author Informationhttps://doi.org/10.1097/01.ju.0000139320.78673.2aAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Chemoprevention may significantly impact the natural history of prostate cancer. The most potent intraprostatic androgen, dihydrotestosterone, has a significant role in the pathophysiology of prostate cancer. It represents a biologically plausible target for chemoprevention through the inhibition of 5α-reductase isoenzymes. Materials and Methods: The Reduction by Dutasteride of Prostate Cancer Events clinical trial is an international, multicenter, double-blind, placebo controlled chemoprevention study designed to determine if dutasteride 0.5 mg daily decreases the risk of biopsy detectable prostate cancer. A total of 8,000 men will be randomized to receive dutasteride or placebo for 4 years. Eligible men must be 50 to 75 years old, have a serum prostate specific antigen of 2.5 to 10 ng/ml (ages 50 to 60 years) or 3.0 to 10 ng/ml (older than 60 years). Men must have a negative 6 to 12 core biopsy within 6 months prior to enrollment. Repeat biopsies will be taken at 2 and 4 years. The rates of prostate cancer for each treatment group will be compared. Genetic and protein biomarkers of prostate cancer, and the effect of dutasteride on benign prostatic hyperplasia and prostatitis symptomatology and histopathology will also be assessed. Results: Results remain to be determined. Conclusions: The study will examine the effects of the dual 5α-reductase inhibitor dutasteride on the natural history of prostate cancer in men at increased risk for this malignancy. 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Google Scholar From the Washington University School of Medicine (GA), St. Louis, Missouri, Bostwick Laboratories (DB), Richmond, Virginia, Emory University School of Medicine (OB), Atlanta, Georgia, Thomas Jefferson University (LG), Philadelphia, Pennsylvania, University of Vienna (MM), Vienna, Austria, Mayo Clinic (DT), Rochester, Minnesota, and GlaxoSmithKline (SB, MS, RR), Research Triangle Park, North Carolina© 2004 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byBranche B, Howard L, Moreira D, Roehrborn C, Castro-Santamaria R, Andriole G, Hopp M and Freedland S (2018) Sleep Problems are Associated with Development and Progression of Lower Urinary Tract Symptoms: Results from REDUCEJournal of Urology, VOL. 199, NO. 2, (536-542), Online publication date: 1-Feb-2018.Jamnagerwalla J, Howard L, Vidal A, Moreira D, Castro-Santamaria R, Andriole G and Freedland S (2018) The Association between Phosphodiesterase Type 5 Inhibitors and Prostate Cancer: 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Volume 172Issue 4 Part 1October 2004Page: 1314-1317 Advertisement Copyright & Permissions© 2004 by American Urological Association, Inc.Keywordsprostatic neoplasmsprostateMetricsAuthor Information GERALD ANDRIOLE Financial interest and/or other relationship with Abbott Laboratories, Antigenics, Bambridge Scientific, Barr Laboratories, Bion Diagnostic, C. D. Searle, Cell Pathways, GlaxoSmithKline, Merck, Pharmacia and Zeneca. More articles by this author DAVID BOSTWICK Financial interest and/or other relationship with GlaxoSmithKline, Genotherapeutics, DiagnoCure, PhotoCure, AstraZeneca, Bostwick Laboratories, Medlon and Endocare. More articles by this author OTIS BRAWLEY Financial interest and/or other relationship with Theragenics, Merck, GlaxoSmithKline and Sanofi. More articles by this author LEONARD GOMELLA Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author MICHAEL MARBERGER Financial interest and/or other relationship with MSD and GlaxoSmithKline. More articles by this author DONALD TINDALL Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author SHARON BREED Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author MATT SOMERVILLE Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author ROGER RITTMASTER Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author REDUCE STUDY GROUP More articles by this author Expand All Advertisement PDF downloadLoading ...