Comparison of clinical effect of different initiation timing of dutasteride for Benign Prostate Hyperplasia (BPH) on multicentre, observational, retrospective, chart review study

Trial description: Medical treatment for BPH in Japan consists of alpha 1‐blocker (a1B), 5-alpha‐reductase inhibitor (5‐ARI), and/or phosphodiesterase‐5 (PDE‐5) inhibitor. Dutasteride is a 5‐ARI that has been approved in Japan for treatment of BPH in subjects with prostate volume (PV) of 30 milliliters (mL) and greater. The combination therapy with 5‐ARI and a1B has been recommended for subjects with PV 30 mL and greater in the Japanese guidelines; however, the early use of combination therapy has not been widely accepted in clinical practice of BPH in Japan. This study was planned to evaluate the effect of dutasteride early add‐on compared to late add‐on in Japanese BPH subjects with PV 30 mL and greater in a real‐world setting. This is a multicenter, observational, retrospective chart review study in Japanese moderate to severe BPH subjects having prescription history with dutasteride following initial diagnosis of BPH at the study sites. Data analysis methods will be categorized into three cohort groups i.e., early initiation group (early add-on), intermediate initiation group (intermediate add-on) and late initiation (late add-on) group based on the initiation timing of dutasteride. Anonymized data will be collected from the medical records of approximately 2500 Japanese BPH subjects from January 2010 to September 2018.