[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514152":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":49,"responsibleParty":160,"collaborators":162,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":47,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":47,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - continuous treatment","ACTIVE_COMPARATOR","Arm A (cMAB): ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide) continuously until start of a new anti-cancer therapy.",[13],"Drug: cMAB",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B - intermittent treatment","EXPERIMENTAL","Arm B (iMAB): no further treatment, including ADT and ARPI; decision to restart ADT (LHRH agonist or antagonist) and the initial ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) is left at Investigator discretion.",[19],"Drug: iMAB",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","iMAB","no treatment until significant PSA increase as per treating physician at which point patient restarts ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide). Once PSA \\\u003C 0.2 ng\u002FmL, treatment stops again.",[15],[27],"intermittent maximum androgen blockade",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"cMAB","LHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)",[9],[33],"continuous maximum androgen blockade",[35,39],{"name":36,"affiliation":37,"role":38},"Bertrand Tombal, Prof","Cliniques Universitaires de Saint Luc","STUDY_CHAIR",{"name":40,"affiliation":41,"role":38},"Silke Gillessen, Prof","Oncology Institute of Southern Switzerland - Ospedale San Giovanni",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"EORTC","CONTACT","+3227741611",null,"eortc@eortc.org",[50,65,79,90,101,112,124,138,149],{"facility":51,"status":52,"city":53,"state":47,"zip":47,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospitals Copenhagen - Rigshospitalet","RECRUITING","Copenhagen","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],12.56553,55.67594,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":47,"phoneExt":47,"email":47},"Martin Andreas Roeder Martin Andreas, Dr",{"facility":66,"status":52,"city":67,"state":47,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Centre Francois Baclesse","Caen","14076","France","FR",{"type":57,"coordinates":72},[73,74],-0.35912,49.18585,{"lat":74,"lon":73},[77],{"name":78,"role":45,"phone":47,"phoneExt":47,"email":47},"Florence Joly, Dr",{"facility":80,"status":52,"city":81,"state":47,"zip":47,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Institut Daniel Hollard","Grenoble",{"type":57,"coordinates":83},[84,85],5.71479,45.17869,{"lat":85,"lon":84},[88],{"name":89,"role":45,"phone":47,"phoneExt":47,"email":47},"Valentine Ruste, Dr",{"facility":91,"status":52,"city":92,"state":47,"zip":47,"country":69,"countryCode":70,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Clinique La Croix Du Sud","Quint-Fonsegrives",{"type":57,"coordinates":94},[95,96],1.5272,43.5852,{"lat":96,"lon":95},[99],{"name":100,"role":45,"phone":47,"phoneExt":47,"email":47},"Guillaume Ploussard, Dr",{"facility":102,"status":52,"city":103,"state":47,"zip":47,"country":69,"countryCode":70,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole","Toulouse",{"type":57,"coordinates":105},[106,107],1.44367,43.60426,{"lat":107,"lon":106},[110],{"name":111,"role":45,"phone":47,"phoneExt":47,"email":47},"Loic Mourey, Dr",{"facility":113,"status":52,"city":114,"state":47,"zip":115,"country":69,"countryCode":70,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Gustave Roussy","Villejuif","94805",{"type":57,"coordinates":117},[118,119],2.35992,48.7939,{"lat":119,"lon":118},[122],{"name":123,"role":45,"phone":47,"phoneExt":47,"email":47},"Anna Patrikidou, Dr",{"facility":125,"status":52,"city":126,"state":47,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Hospital De La Santa Creu I Sant Pau","Barcelona","08041","Spain","ES",{"type":57,"coordinates":131},[132,133],2.15899,41.38879,{"lat":133,"lon":132},[136],{"name":137,"role":45,"phone":47,"phoneExt":47,"email":47},"Pablo Maroto, Dr",{"facility":139,"status":52,"city":140,"state":47,"zip":47,"country":128,"countryCode":129,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hospital Universitario San Carlos","Madrid",{"type":57,"coordinates":142},[143,144],-3.70256,40.4165,{"lat":144,"lon":143},[147],{"name":148,"role":45,"phone":47,"phoneExt":47,"email":47},"Javier Puente, Dr",{"facility":150,"status":52,"city":151,"state":47,"zip":47,"country":128,"countryCode":129,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital Universitario Puerta De Hierro","Majadahonda",{"type":57,"coordinates":153},[154,155],-3.87182,40.47353,{"lat":155,"lon":154},[158],{"name":159,"role":45,"phone":47,"phoneExt":47,"email":47},"Aranzazu Gonzalez del Alba, Dr",{"type":161,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[163,165,168],{"name":164,"class":6},"Cancer Trials Ireland",{"name":166,"class":167},"UNICANCER","OTHER",{"name":169,"class":167},"Spanish Oncology Genito-Urinary Group","100514152","phase-3-intermittent-androgen-deprivation-therapy-in-the-era-of-ar-pathway-inhibitors-100514152",false,"NCT05974774","Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors","Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.","Inclusion Criteria:\n\n* Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng\u002FmL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume\u002Frisk or low volume\u002Frisk who fulfil the criteria can be included.\n* Before patient 's enrolment, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned\n* Patients who underwent or will undergo a bilateral orchiectomy\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial\n* Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial","MALE","18 Years","100 Years",{"count":181,"type":182},1600,"ESTIMATED","INTERVENTIONAL",[185],"PHASE3","This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization.\n\nThe primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.",[188],"Prostate Cancer",[190],"Metastatic hormone-naïve prostate cancer","2025-09-15",{"date":193,"type":194},"2025-09-19","ACTUAL",{"date":196,"type":194},"2025-05-23",{"date":198,"type":182},"2039-06-01",{"name":5,"class":6},9]