[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595346":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":19,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":7,"eligibilityCriteria":27,"healthyVolunteers":23,"sex":28,"minAge":29,"maxAge":7,"enrollmentInfo":30,"targetDuration":33,"studyType":34,"phases":7,"briefSummary":35,"conditions":36,"keywords":7,"overallStatus":39,"whyStopped":7,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":7},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Dose of docetaxel","According to the relative dose intensity of docetaxel (RDI; Defined as the ratio of the dose received to the full planned dose of 75mg\u002Fm2 per 6 cycles specified in the protocol) were divided into cohort 1 (patients receiving docetaxel dose intensity ≤80%) and cohort 2 (patients receiving docetaxel dose intensity ≤80%). A total of 50 patients who received docetaxel dose intensity \\> 80% were planned to be enrolled, including 25 patients in the docetaxel dose intensity ≤80% group and 25 patients in the docetaxel dose intensity \\> 80% group",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Wu Y Wang","CONTACT","China+15066541238","1470329253@qq.com",{"type":20,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100595346","evaluation-of-the-efficacy-of-darolutamide-triplet-therapy-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100595346",false,"NCT07031258","Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer","Prospective Real-world Data Evaluation of Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC) in Patients With Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\nVoluntarily signed informed consent form and able to understand and agree to comply with study requirements; Age ≥18； Male； Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc.； Patients determined by treating physician to require darolutamide triplet therapy ECOG performance status score of 0-1 as evaluated by the Eastern Cooperative Oncology Group (ECOG) criteria； Life expectancy of over 1 year； Good compliance with regular serum PSA testing during treatment；\n\nExclusion Criteria:\n\nPresence of other malignancies within the past 2 years or currently; Severe cardiovascular\u002Fcerebrovascular disease within 6 months prior to study treatment initiation, including: severe\u002Funstable angina, myocardial infarction, congestive heart failure \\[NYHA Class III or worse\\], stroke, or arrhythmia requiring medication; Allergy to any study drug or excipient; Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake\u002Fabsorption; Underlying medical condition\u002Falcohol or drug abuse\u002Fdependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; Participation in another therapeutic clinical study; Deemed unsuitable for the study by the investigator.","MALE","18 Years",{"count":31,"type":32},50,"ESTIMATED","1 Year","OBSERVATIONAL","The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with metastatic hormone-sensitive prostate cancer.",[37,38],"Metastatic Hormone-sensitive Prostate Cancer","Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)","NOT_YET_RECRUITING","2025-06-12",{"date":42,"type":43},"2025-06-22","ACTUAL",{"date":45,"type":32},"2025-06",{"date":47,"type":32},"2027-06",{"name":5,"class":6}]