[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571314":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":32,"responsibleParty":48,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Ente Ospedaliero Ospedali Galliera","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Low Dose of Enzalutamide",null,"Low Dose of Enzalutamide: ≤ 50% of the standard dose",{"label":13,"type":10,"description":14,"interventionNames":10},"Intermediate Dose of Enzalutamide","Intermediate Dose of Enzalutamide: \\> 50% and ≤ 80% of the standard dose",{"label":16,"type":10,"description":17,"interventionNames":10},"High Dose of Enzalutamide","High Dose of Enzalutamide: \\> 80% of the standard dose",[19],{"name":20,"affiliation":5,"role":21},"Andrea De Censi","STUDY_CHAIR",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Monica Boitano","CONTACT","00390105634505","monica.boitano@galliera.it",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Martino Oliva","00390105634506","martino.oliva@galliera.it",[33],{"facility":5,"status":10,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Genoa","GENOA","16128","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],8.94439,44.40478,{"lat":43,"lon":42},[46],{"name":29,"role":25,"phone":47,"phoneExt":10,"email":31},"+390105634506",{"type":49,"investigatorFullName":24,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Scientific Coordinator","100571314","efficacy-and-tolerability-of-low-dose-enzalutamide-in-prostate-cancer-100571314",false,"NCT06718647","Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer","Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study","LODE","Inclusion Criteria:\n\n* Patients with histological diagnosis metastatic prostate cancer;\n* Enzalutamide therapy taken between 01\u002F08\u002F2014 and 31\u002F12\u002F2023;\n* Age ≥ 18 years;\n* Signed Informed consent.\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease for example cerebrovascular accidents (\\\u003C=6 months), myocardial infarction (\\\u003C=3 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); uncontrolled hypertension or bradycardia\n* Patients who died within one month of starting treatment with Enzalutamide for all causes;\n* Uncontrolled concomitant diseases.","MALE","18 Years",{"count":62,"type":63},150,"ESTIMATED","OBSERVATIONAL","Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.\n\nBased on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.",[67],"Prostate Cancer Metastatic Disease",[69,70,71,72,73,74],"Enzalutamide","Low-Doses","Prostatic neoplasms","Elderly","Adverse event","Metastatic prostate cancer","NOT_YET_RECRUITING","2025-07-11",{"date":78,"type":79},"2025-07-16","ACTUAL",{"date":81,"type":63},"2025-09-01",{"date":83,"type":63},"2025-12-31",{"name":24,"class":6},1]