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.

本项为期4年的临床试验将对比口服研究性药物（与安慰剂对照）在预防符合入组标准的前列腺癌高危男性人群发生前列腺癌方面的安全性与有效性。研究期间，受试者需每6个月前往临床中心进行1次随访，全程最长可达4年，共计10次临床访视；并将在治疗第2年及第4年时分别实施前列腺活检。