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

Condition(s) studied

Investigational drug(s) / intervention(s)

Darolutamide (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.

Study 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

Primary outcome measure(s)

• Number, severity of adverse events (including SAEs) — From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
  SAE stands for serious adverse event. An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
• Number, severity of adverse drug reactions (including SADRs) — From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
  SADR stands for serious adverse drug reaction. An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
• The outcome of (serious) adverse events — From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
  An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
• The outcome of (serious) adverse drug reactions — From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
  An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.

Trial sites (1)

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