This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care. The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.
Study Type
OBSERVATIONAL
Enrollment
50
Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT). 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.
Many locations
Many Locations, India
Incidence and severity of adverse events and serious adverse events
Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
Time frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Incidence of discontinuations and dose modifications of study drug due to adverse events
Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
Time frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Changes in hematology laboratory parameters: hemoglobin
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: hematocrit
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: erythrocyte count
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: leukocyte count
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: lymphocytes
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: monocytes
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: eosinophils
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: neutrophils
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: basophils
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular volume
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: thrombocytes
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: albumin
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: calcium
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: creatinine
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: serum glucose
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total protein
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: sodium
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: potassium
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: chloride
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bicarbonate
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: testosterone
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: prothrombin time
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: specific gravity
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: pH, by dipstick
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: glucose, by dipstick
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: protein, by dipstick
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: blood, by dipstick
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: ketones, by dipstick
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: microscopic examination
Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests
Results of other safety laboratory tests performed as deemed necessary by the investigator
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in Eastern Cooperative Oncology Group performance status and vitals
Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
Time frame: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Incidence and severity of adverse events categorized as special topics
Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as: * hypertension * vasodilatation and flushing * diabetes mellitus and hyperglycemia * cardiac arrhythmias * fatigue * rash * bone fracture, excluding pathological fractures * coronary artery disorders * decreased weight * mental-impairment disorder * falls, including accident * heart failure * depressed-mood disorder * seizures * gynecomastia * cerebral ischemia.
Time frame: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Drug administration status
Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
Time frame: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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