Prostate Safety End Points
high-grade prostate cancer, acute urinary retention, prostate
BPH, PROSTATE CANCER, PROSTATE
The primary prostate safety end point was the incidence of high-grade prostate cancer (Gleason score 4 + 3 or higher). Secondary end points included the incidence of any prostate cancer, acute urinary retention, invasive prostate surgical procedure for BPH, prostate biopsy, and new pharmacologic treatment for LUTSs. The LUTSs were evaluated using the IPSS. Changes in PSA concentrations from baseline and from month 12 were determined.