protocolSection identificationModule nctId: NCT06334120, orgStudyIdInfo id: 20654, briefTitle: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Non-metastatic Castration-resistant Prostate Cancer, conditions: Metastatic Hormone-sensitive Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Darolutamide (Nubeqa, BAY1841788), outcomesModule primaryOutcomes measure: Number, severity of adverse events (including SAEs), primaryOutcomes measure: Number, severity of adverse drug reactions (including SADRs), primaryOutcomes measure: The outcome of (serious) adverse events, primaryOutcomes measure: The outcome of (serious) adverse drug reactions, secondaryOutcomes measure: Metastasis-free survival (MFS), secondaryOutcomes measure: Time to symptomatic skeletal event (SSE), secondaryOutcomes measure: Time to prostate-specific antigen (PSA) progression, secondaryOutcomes measure: Number of patients with metastasis of castration-resistant prostate cancer (mCRPC), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Duration of Darolutamide treatment, secondaryOutcomes measure: Reasons for ending Darolutamide, secondaryOutcomes measure: Dosage and dose modification of Darolutamide, eligibilityModule sex: MALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Multiple locations, city: Multiple Locations, country: Korea, Republic of, hasResults: False