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.
Study Type
OBSERVATIONAL
Enrollment
600
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.
Multiple locations
Multiple Locations, South Korea
RECRUITINGNumber, 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.
Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
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.
Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
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.
Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
The outcome of (serious) adverse drug reactions
An ADR is any AE judged by investigator as having a reasonable suspected causal relationship to Darolutamide.
Time frame: From the date that the patient signed the informed consent to 30 days after the end of the treatment (up to 52 weeks)
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 frame: Up to 52 weeks
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 frame: Up to 52 weeks
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.
Time frame: Up to 52 weeks
Overall survival by nmCRPC indication
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
Time frame: Up to 52 weeks
Time to Castration-Resistant Prostate Cancer (CRPC) by mHSPC indication
Time to mCRPC, defined as the time to PSA progression with serum testosterone being at castrate level \<0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions, whatever comes first.
Time frame: Up to 52 weeks
Time to first symptomatic skeletal event (SSE) by mHSPC 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 frame: Up to 52 weeks
Time to prostate-specific antigen (PSA) progression by mHSPC 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.
Time frame: Up to 52 weeks
Overall survival by mHSPC indication
Overall survival is defined as the time (months) from the initiation of Darolutamide treatment until death from any cause.
Time frame: Up to 52 weeks
Time to initiation of subsequent anti-cancer therapy by mHSPC indication
Time to initiation of subsequent anti-cancer therapy is defined as the time (months) from the initiation of Darolutamide treatment to the date of first administration of any subsequent anti-cancer therapy after discontinuation of Darolutamide.
Time frame: Up to 52 weeks
Radiological progression (Soft tissue/ Bone metastasis) by mHSPC indication
Radiological progression is defined as the time (months) from the start of Darolutamide treatment to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.
Time frame: Up to 52 weeks
Radiological Progression-Free Survival (rPFS) by mHSPC indication
Radiographic Progression-Free Survival (rPFS) is defined as the time (months) from the initiation of Darolutamide treatment to the date of the first radiologically confirmed disease progression or death from any cause, whichever occurs first.
Time frame: Up to 52 weeks
Duration of Darolutamide treatment
Duration of Darolutamide treatment is defined as the time (months) from the start of Darolutamide treatment to the day of permanent discontinuation of Darolutamide (including death).
Time frame: Up to 52 weeks
Reasons for ending Darolutamide
Time frame: Up to 52 weeks
Dosage and dose modification of Darolutamide
Time frame: Up to 52 weeks
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