An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels. This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth. To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants. During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors. Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku co najmniej 19 lat
- •Rak prostaty, który nie rozprzestrzenił się i nie reaguje na obniżenie poziomu testosteronu, z wysokim ryzykiem
- •Rak prostaty, który rozprzestrzenił się na inne części ciała i reaguje na obniżenie testosteronu
- •Pacjent, u którego lekarz zdecydował się na pierwszorazowe zastosowanie leku darolutamid
- •Pisemna zgoda pacjenta lub jego przedstawiciela prawnego
✗ Disqualifies
- •Uczestnictwo w innym badaniu eksperymentalnym poza standardową praktyką kliniczną
- •Pacjent, u którego lek jest przeciwwskazany zgodnie z instrukcją stosowania
Simplified criteria — AI translation
Trial details
- Minimum age
- 19 Years
- Last updated (source)
- August 3, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Many locations
Multiple Locations, South Korea
Trial contact
Bayer Clinical Trials Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.
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