Observing Safety and Effectiveness of Darolutamide with Androgen Deprivation Therapy and Docetaxel in Japanese Men with Low-Volume Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are observing adult Japanese men with low-volume metastatic hormone-sensitive prostate cancer mHSPC who are receiving a combination therapy of darolutamide, androgen deprivation therapy ADT, and docetaxel during routine medical care. This study aims to understand the safety and effects of this combination therapy in real-world clinical settings, as darolutamide is approved for a related prostate cancer type but requires further study for this specific group. Participants receive darolutamide together with ADT and docetaxel as prescribed by their doctors in standard medical practice. No treatment changes or advice are given as part of the study. Data collection occurs from October 2024 to June 2031, drawing from medical records without any extra visits or interventions required for participants. Participants will continue their usual care visits, and researchers will gather information from medical records to assess prostate-specific antigen PSA levels, adverse events related to treatment, and other clinical outcomes over 12 months. The main outcomes include the proportion of patients achieving normal PSA levels and the frequency of adverse events leading to changes or discontinuation of darolutamide or docetaxel. Secondary measures include time to PSA progression, development of castration-resistant prostate cancer, and treatment patterns among others.

A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer