[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655033":3},{"organization":4,"outcomesModule":7,"designInfo":113,"detailedDescription":19,"studyPopulation":116,"armGroups":117,"interventions":123,"overallOfficials":19,"centralContacts":132,"locations":138,"responsibleParty":144,"collaborators":19,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":19,"enrollmentInfo":156,"targetDuration":19,"studyType":159,"phases":19,"briefSummary":160,"conditions":161,"keywords":19,"overallStatus":163,"whyStopped":19,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Bayer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events and serious adverse events","Occurrence of adverse events, including AE\u002FSAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria","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",{"measure":14,"description":15,"timeFrame":12},"Incidence of discontinuations and dose modifications of study drug due to adverse events","Adverse event-related drug discontinuations\u002Fmodifications, including adverse events leading to dose modification\u002Fdiscontinuation, dates, and reason",[17,21,23,25,27,29,31,33,35,37,39,41,43,45,47,49,51,53,55,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95,97,100,103,106,109],{"measure":18,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: hemoglobin",null,"Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months",{"measure":22,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: hematocrit",{"measure":24,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: erythrocyte count",{"measure":26,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: leukocyte count",{"measure":28,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: lymphocytes",{"measure":30,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: monocytes",{"measure":32,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: eosinophils",{"measure":34,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: neutrophils",{"measure":36,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: basophils",{"measure":38,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: mean corpuscular hemoglobin",{"measure":40,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: mean corpuscular volume",{"measure":42,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration",{"measure":44,"description":19,"timeFrame":20},"Changes in hematology laboratory parameters: thrombocytes",{"measure":46,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: albumin",{"measure":48,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: alanine aminotransferase",{"measure":50,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: aspartate aminotransferase",{"measure":52,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: alkaline phosphatase",{"measure":54,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase",{"measure":56,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: bilirubin total and direct",{"measure":58,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: calcium",{"measure":60,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: blood urea nitrogen",{"measure":62,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: creatinine",{"measure":64,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: serum glucose",{"measure":66,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: total protein",{"measure":68,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: lactate dehydrogenase",{"measure":70,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: sodium",{"measure":72,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: potassium",{"measure":74,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: chloride",{"measure":76,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: bicarbonate",{"measure":78,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: testosterone",{"measure":80,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)",{"measure":82,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: prothrombin time",{"measure":84,"description":19,"timeFrame":20},"Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)",{"measure":86,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: specific gravity",{"measure":88,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: pH, by dipstick",{"measure":90,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: glucose, by dipstick",{"measure":92,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: protein, by dipstick",{"measure":94,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: blood, by dipstick",{"measure":96,"description":19,"timeFrame":20},"Changes in routine urinalysis parameters: ketones, by dipstick",{"measure":98,"description":99,"timeFrame":20},"Changes in routine urinalysis parameters: microscopic examination","Microscopic examination, if blood or protein urinalysis by dipstick is abnormal",{"measure":101,"description":102,"timeFrame":20},"Results of other safety laboratory tests","Results of other safety laboratory tests performed as deemed necessary by the investigator",{"measure":104,"description":105,"timeFrame":20},"Changes in Eastern Cooperative Oncology Group performance status and vitals","Eastern Cooperative Oncology Group performance status on a scale from 0 to 5",{"measure":107,"description":108,"timeFrame":12},"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:\n\n* hypertension\n* vasodilatation and flushing\n* diabetes mellitus and hyperglycemia\n* cardiac arrhythmias\n* fatigue\n* rash\n* bone fracture, excluding pathological fractures\n* coronary artery disorders\n* decreased weight\n* mental-impairment disorder\n* falls, including accident\n* heart failure\n* depressed-mood disorder\n* seizures\n* gynecomastia\n* cerebral ischemia.",{"measure":110,"description":111,"timeFrame":112},"Drug administration status","Drug exposure and modifications, including start\u002Fstop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose","From baseline\u002Ffirst dose through the treatment and observation period, over a total duration of approximately 12 months",{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":114,"timePerspective":115,"maskingInfo":19},"COHORT","PROSPECTIVE","Male patients with a diagnosis of metastatic hormone sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with darolutamide has been made by the physician.",[118],{"label":119,"type":19,"description":120,"interventionNames":121},"Single-arm post marketing surveillance cohort","Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice",[122],"Drug: Darolutamide plus androgen deprivation therapy",[124],{"type":125,"name":126,"description":127,"armGroupLabels":128,"otherNames":129},"DRUG","Darolutamide plus androgen deprivation therapy","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.",[119],[130,131],"NUBEQA","BAY 1841788",[133],{"name":134,"role":135,"phone":136,"phoneExt":19,"email":137},"Bayer Clinical Trials Contact","CONTACT","4930300139003","clinical-trials-contact@bayer.com",[139],{"facility":140,"status":19,"city":141,"state":19,"zip":19,"country":142,"countryCode":143,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Many locations","Many Locations","India","IN",{"type":145,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100655033","a-study-of-darolutamide-plus-androgen-deprivation-therapy-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-in-india-100655033",false,"NCT07806591","A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India","An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","PACE mHSPC","Inclusion Criteria:\n\n* Men over the age of 18 years\n* Histologically or cytologically confirmed adenocarcinoma of prostate\n* Metastatic disease (metastatic hormone sensitive prostate cancer) documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigators\n* The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice\n* Written informed consent\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial program with interventions outside of routine clinical practice\n* Any condition that, in investigator's opinion, precludes reliable safety follow-up.\n* Concomitant use or planned to start the use of docetaxel\u002Fany other androgen receptor inhibitors\u002Fradiation therapy\u002Fchemotherapy or immunotherapy\n* Known hypersensitivity to the study drug or any of its ingredients\n* Metastatic castration resistant prostate cancer (mCRPC) disease","MALE","18 Years",{"count":157,"type":158},50,"ESTIMATED","OBSERVATIONAL","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.",[162],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","NOT_YET_RECRUITING","2026-09-09",{"date":166,"type":167},"2026-09-10","ACTUAL",{"date":169,"type":158},"2026-10-05",{"date":171,"type":158},"2028-10-31",{"name":5,"class":6},1]