RecruitingNCT06334120

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

Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients


Sponsor

Bayer

Enrollment

600 participants

Start Date

Sep 25, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world safety and effectiveness data on darolutamide — a hormone-blocking drug — in men with advanced prostate cancer. Researchers want to understand how the drug performs in routine clinical practice outside of controlled trials. **You may be eligible if...** - You are a male aged 19 or older - You have been diagnosed with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC), meaning the cancer hasn't spread but is progressing despite low testosterone levels - OR you have metastatic hormone-sensitive prostate cancer (mHSPC) - Your doctor has decided to start you on darolutamide as part of standard care **You may NOT be eligible if...** - You are already enrolled in another interventional clinical trial - You have previously been treated with darolutamide - You have conditions that your doctor believes would make this treatment inappropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarolutamide (Nubeqa, BAY1841788)

The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.


Locations(1)

Multiple locations

Multiple Locations, South Korea

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NCT06334120


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