Observational Safety Study of Darolutamide in Korean Men with Non-Metastatic Castration-Resistant or Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are observing the safety of darolutamide in Korean men with two types of prostate cancer non-metastatic castration-resistant prostate cancer nmCRPC, which has not spread and does not respond to testosterone reduction, and metastatic hormone-sensitive prostate cancer mHSPC, which has spread but can be treated by lowering testosterone. Darolutamide is a drug that blocks hormones from binding to androgen receptors in prostate cells, potentially slowing cancer growth. This observational study focuses on men who have already been prescribed darolutamide by their doctors. Participants will continue their usual care while being observed for up to one year. They will visit their doctors every 2 to 4 months for scans to monitor cancer and blood tests. Researchers will collect data from medical records about adverse events, medication use, and how well darolutamide is working. The dose and duration of darolutamide are determined by their doctors following local guidelines. Throughout the study, doctors will track the number and severity of any adverse events or drug reactions, including serious cases, from the time patients consent until 30 days after treatment ends. Participants will answer questions about their medications and health. Researchers will also monitor cancer progression and survival outcomes. The entire study will last about six years, with each participant involved for about one year.

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea