Actively Recruiting
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Led by Bayer · Updated on 2026-05-13
600
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 19 years or older
- Patients with high risk non-metastatic castration-resistant prostate cancer (nmCRPC) with castrate level serum testosterone (< 1.7 nmol/l [50 ng/dL]) and PSA doubling time under 10 months
- Patients with metastatic hormone-sensitive prostate cancer (mHSPC) confirmed by biopsy and metastases detected on bone scan, CT, or MRI
- Candidates for androgen-deprivation therapy with or without docetaxel
- Patients starting darolutamide treatment for the first time as decided by their doctor
- Written informed consent provided by the patient or legal representative; assent from patient when appropriate
You will not qualify if you...
- Participation in investigational programs with interventions outside routine clinical practice
- Contraindications to darolutamide according to locally approved prescribing information
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Multiple locations
Multiple Locations, South Korea
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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