Real-world Study of Darolutamide and Other Androgen Receptor Pathway Inhibitors for Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer in US Urology Clinics

What this Trial Is About

Prostate cancer is the most common non-skin cancer among men in the United States. This research focuses on men newly diagnosed with metastatic hormone-sensitive prostate cancer mHSPC, where cancer has spread beyond the prostate. The study aims to understand how darolutamide, an androgen receptor pathway inhibitor ARPI, is used in real-world settings, either with androgen deprivation therapy ADT alone or combined with docetaxel chemotherapy. It also examines other ARPIs like abiraterone acetate, enzalutamide, and apalutamide, to gather clinical and demographic data and support future comparative studies. Participants are grouped based on their treatment regimens, including darolutamide with ADT plus docetaxel triplet therapy, darolutamide with ADT alone doublet therapy, and other ARPIs combined with ADT, with or without docetaxel. The study collects retrospective data from electronic medical records across community urology clinics in the US to evaluate drug use patterns, doses, treatment interruptions, and switches to other ARPIs up to 39 months after treatment starts. Throughout the study, researchers will analyze patient characteristics such as age, ethnicity, comorbidities, and PSA levels at baseline. They will track treatment outcomes including PSA response, adverse events, initiation of next therapies, progression to castration-resistant prostate cancer, and mortality. Data collection covers periods before treatment, during therapy, and up to 30 days after treatment ends. This observational study offers insights into real-world management of mHSPC over a study period ending in September 2026.

A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics