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.
Male aged ≥19 years
Patients with high risk nmCPRC
Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL])
PSA doubling time < 10 months
Patients participating in an investigational program with interventions outside of routine clinical practice
Participants with contraindication according to the locally approved prescribing information
Patients who have been prescribed Darolutamide for a medically appropriate use will be eligible to be enrolled.
Cohort
Prospective
Darolutamide (Nubeqa, BAY1841788)
DrugThe 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.
Number, severity of adverse events (including SAEs)
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)
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
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
An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
Metastasis-free survival (MFS) by nmCRPC indication
MFS is defined as the time (months) from the initiation of Darolutamide treatment to the date of first observed metastasis.
Time to first symptomatic skeletal event (SSE) by nmCRPC indication
Time to SSE is defined as the time (months) from the initiation of Darolutamide treatment to the date of first diagnosed skeletal-related event.
Time to prostate-specific antigen (PSA) progression by nmCRPC indication
Time to PSA progression is defined as the time (months) from the initiation of Darolutamide treatment to the date at which PSA is recorded at ≥25% increase above the nadir (lowest screening or baseline) value along with an increase in absolute value of ≥2 ng/mL above nadir.
Overall survival by nmCRPC indication
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
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