Main Outcomes and Measures
high-grade prostate cancer, acute urinary retention, prostate
PROSTATE CANCER, PROSTATE
The primary prostate safety end point was the incidence of adjudicated high-grade prostate cancer. Secondary end points included incidence of any adjudicated prostate cancer, acute urinary retention, invasive prostate surgical procedure, prostate biopsy, and new pharmacologic treatment. Intervention effect was analyzed using a discrete-time proportional hazards model.