A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
Inclusion criteria:
Exclusion criteria:
Wocester, Massachusetts 01608, United States
Lawrencevill, New Jersey 08648, United States
Poca City, Oklahoma 74601, United States
Av Córdoba 2424, Buenos Aires 1120, Argentina
Capital Federal, Buenos Aires 1425, Argentina
Capital Federal, Buenos Aires 1437, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1405BCH, Argentina
North York, Ontario M3B 3P1, Canada
Kleinblittersdorf, Baden-Wurttemberg 66271, Germany
Wertheim, Bavaria 97877, Germany
Hagenow, Brandenburg 19230, Germany
Wedel, Free and Hanseatic City of Hamburg 22880, Germany
Hemmoor, Schleswig-Holstein 21745, Germany
Rio, Patras, 265 00, Greece
Napoli, Veneto 80131, Italy
Hokkaido, 060-8543, Japan
Zapopan, Jalisco, Jalisco 45100, Mexico
Westville, Durban, 3630, South Africa
Galdakano, 48960, Spain
Via-Real (Castellón), 12540, Spain
Capa/Istanbul, Turkey (Türkiye)
Lancs, Lancashire PR7 1PP, United Kingdom
Tauton, Somerset TA1 5DA, United Kingdom
Clydebank, Glasgow, G81 2DR, United Kingdom
Edgbaston, Birmingham, B15 2SQ, United Kingdom
Waterloo, Liverpool, L22 0LG, United Kingdom