[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648071":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":269,"collaborators":271,"id":274,"slug":275,"hasResults":276,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":276,"sex":282,"minAge":21,"maxAge":21,"enrollmentInfo":283,"targetDuration":21,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":64,"whyStopped":21,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},{"fullName":5,"class":6},"Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Second generation antiandrogen plus SBRT","Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and\u002For exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and\u002For exitus",[12,13,14],"Drug: Xtandi","Drug: Zytiga® (Abiraterone Acetate)","Radiation: SBRT",[16,22,27],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Xtandi","Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and\u002For exitus)",[9],null,{"type":17,"name":23,"description":19,"armGroupLabels":24,"otherNames":25},"Zytiga® (Abiraterone Acetate)",[9],[26],"abiraterone acetate",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":21},"RADIATION","SBRT","SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and\u002For exitus",[9],[33],{"name":34,"affiliation":35,"role":36},"Marta Barrado Los Arcos, MD","Hospital of Navarra","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":21,"email":42},"Pablo Raña Diez, PhD","CONTACT","+34 696633409","investigacion@seor.es",{"name":44,"role":40,"phone":45,"phoneExt":21,"email":46},"Cristina Gutierrez Povedano, PhD","+34 675039150","cristina.gutierrez.povedano@navarra.es",[48,62,85,101,111,121,136,160,169,179,188,215,240,250,259],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":21},"Hospital Universitario Miguel Servet","ACTIVE_NOT_RECRUITING","Zaragoza","Aragon","50009","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-0.87734,41.65606,{"lat":60,"lon":59},{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospital Clinic de Barcelona","RECRUITING","Barcelona","08036",{"type":57,"coordinates":68},[69,70],2.15899,41.38879,{"lat":70,"lon":69},[73,76,78,81,83],{"name":74,"role":40,"phone":21,"phoneExt":21,"email":75},"Joel Mases, MD","mases@clinic.cat",{"name":77,"role":36,"phone":21,"phoneExt":21,"email":21},"Joel Mases i Rosinés, MD",{"name":79,"role":80,"phone":21,"phoneExt":21,"email":21},"Elías Gomís, MD","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":21,"phoneExt":21,"email":21},"Sara Moreno, MD",{"name":84,"role":80,"phone":21,"phoneExt":21,"email":21},"Gerard Meca, MD",{"facility":86,"status":64,"city":87,"state":65,"zip":88,"country":54,"countryCode":55,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Instituto Catalán de Oncología Hospitalet","L'Hospitalet de Llobregat","08908",{"type":57,"coordinates":90},[91,92],2.10028,41.35967,{"lat":92,"lon":91},[95,99],{"name":96,"role":40,"phone":21,"phoneExt":97,"email":98},"Anna Maria Boladeras, MD","+34 93 260 77","aboladeras@iconcologia.net",{"name":100,"role":36,"phone":21,"phoneExt":21,"email":21},"Ana María Boladeras Inglada, MD",{"facility":102,"status":50,"city":103,"state":104,"zip":105,"country":54,"countryCode":55,"cosmosGeoPoint":106,"geoPoint":110,"contacts":21},"Hospital Universitario Basurto","Bilbao","Basque Country","48013",{"type":57,"coordinates":107},[108,109],-2.92528,43.26271,{"lat":109,"lon":108},{"facility":112,"status":50,"city":113,"state":114,"zip":115,"country":54,"countryCode":55,"cosmosGeoPoint":116,"geoPoint":120,"contacts":21},"Hospital Universitario De Salamanca","Salamanca","Castille and León","37007",{"type":57,"coordinates":117},[118,119],-5.66388,40.96882,{"lat":119,"lon":118},{"facility":122,"status":64,"city":123,"state":114,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Hospital Clínico Universitario De Valladolid","Valladolid","47003",{"type":57,"coordinates":126},[127,128],-4.72353,41.65541,{"lat":128,"lon":127},[131,135],{"name":132,"role":40,"phone":133,"phoneExt":21,"email":134},"Patricia Diezhandino Garcia, MD","+34 983 420 003","pdiezhandino@saludcastillayleon.es",{"name":132,"role":36,"phone":21,"phoneExt":21,"email":21},{"facility":137,"status":64,"city":65,"state":138,"zip":139,"country":54,"countryCode":55,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Hospital De La Santa Creu I Sant Pau","Catalonia","08041",{"type":57,"coordinates":141},[69,70],{"lat":70,"lon":69},[144,148,153,155,156,158],{"name":145,"role":40,"phone":146,"phoneExt":21,"email":147},"Gemma Sancho Pardo, MD","+34 935537756","gsancho@santpau.cat",{"name":149,"role":40,"phone":150,"phoneExt":151,"email":152},"Saudy Peláez Bonilla, Study coordinator","+34 935537760","776","SPelaez@santpau.cat",{"name":154,"role":80,"phone":21,"phoneExt":21,"email":21},"Arantxa Mera Errasti, MD",{"name":145,"role":36,"phone":21,"phoneExt":21,"email":21},{"name":157,"role":80,"phone":21,"phoneExt":21,"email":21},"Laura Montezuma Niño, MD",{"name":159,"role":80,"phone":21,"phoneExt":21,"email":21},"Ana Maria Soto Cambres, MD",{"facility":161,"status":50,"city":162,"state":138,"zip":163,"country":54,"countryCode":55,"cosmosGeoPoint":164,"geoPoint":168,"contacts":21},"Consorci Sanitari De Terrassa","Terrassa","08227",{"type":57,"coordinates":165},[166,167],2.01667,41.56667,{"lat":167,"lon":166},{"facility":170,"status":50,"city":171,"state":172,"zip":173,"country":54,"countryCode":55,"cosmosGeoPoint":174,"geoPoint":178,"contacts":21},"Complexo Hospitalario Universitario De Santiago","Santiago de Compostela","Galicia","15706",{"type":57,"coordinates":175},[176,177],-8.54569,42.88052,{"lat":177,"lon":176},{"facility":180,"status":50,"city":181,"state":181,"zip":182,"country":54,"countryCode":55,"cosmosGeoPoint":183,"geoPoint":187,"contacts":21},"Hospital Ramón y Cajal","Madrid","28034",{"type":57,"coordinates":184},[185,186],-3.70256,40.4165,{"lat":186,"lon":185},{"facility":189,"status":64,"city":181,"state":181,"zip":190,"country":54,"countryCode":55,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"Hospital Clínico San Carlos","28040",{"type":57,"coordinates":192},[185,186],{"lat":186,"lon":185},[195,199,201,203,205,207,209,211,213],{"name":196,"role":40,"phone":197,"phoneExt":21,"email":198},"Noelia Sanmamed, MD","+34 985 10 80 00","noelia.sanmamed@salud.madrid.org",{"name":200,"role":36,"phone":21,"phoneExt":21,"email":21},"Noelia Sanmamed Salgado, MD",{"name":202,"role":80,"phone":21,"phoneExt":21,"email":21},"Manuel Gonzalo Vázquez Masedo, MD",{"name":204,"role":80,"phone":21,"phoneExt":21,"email":21},"Miren Gaztañaga Boronat, MD",{"name":206,"role":80,"phone":21,"phoneExt":21,"email":21},"Maria Nieves Cabrera Martin, MD",{"name":208,"role":80,"phone":21,"phoneExt":21,"email":21},"Natalia Vidal Cassinello, MD",{"name":210,"role":80,"phone":21,"phoneExt":21,"email":21},"Anxela Doval Gonzalez, MD",{"name":212,"role":80,"phone":21,"phoneExt":21,"email":21},"Javier Puente Vazquez, MD",{"name":214,"role":80,"phone":21,"phoneExt":21,"email":21},"Ignacio Moreno, MD",{"facility":216,"status":64,"city":217,"state":218,"zip":219,"country":54,"countryCode":55,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Hospital Universitario de Navarra (HUN)","Pamplona","Navarre","31008",{"type":57,"coordinates":221},[222,223],-1.64323,42.81687,{"lat":223,"lon":222},[226,229,230,232,234,236,238],{"name":34,"role":40,"phone":227,"phoneExt":21,"email":228},"+34 848 42 84 82","marta.barrado.losarcos@navarra.es",{"name":34,"role":36,"phone":21,"phoneExt":21,"email":21},{"name":231,"role":80,"phone":21,"phoneExt":21,"email":21},"Amaya Sola Galarza, MD",{"name":233,"role":80,"phone":21,"phoneExt":21,"email":21},"Elena Villafranca Iturre, MD",{"name":235,"role":80,"phone":21,"phoneExt":21,"email":21},"Ignacio Visus Fernandez de Manzanos, MD",{"name":237,"role":80,"phone":21,"phoneExt":21,"email":21},"Nuria Bultó Boque, MD",{"name":239,"role":80,"phone":21,"phoneExt":21,"email":21},"Xabier Gurutzeaga Peleato, MD",{"facility":241,"status":50,"city":242,"state":243,"zip":244,"country":54,"countryCode":55,"cosmosGeoPoint":245,"geoPoint":249,"contacts":21},"Hospital Universitario Central De Asturias","Oviedo","Principality of Asturias","33011",{"type":57,"coordinates":246},[247,248],-5.84476,43.36029,{"lat":248,"lon":247},{"facility":251,"status":50,"city":252,"state":252,"zip":253,"country":54,"countryCode":55,"cosmosGeoPoint":254,"geoPoint":258,"contacts":21},"Hospital Universitario y Politécnico de La Fe","Valencia","46026",{"type":57,"coordinates":255},[256,257],-0.37966,39.47391,{"lat":257,"lon":256},{"facility":260,"status":50,"city":261,"state":262,"zip":263,"country":54,"countryCode":55,"cosmosGeoPoint":264,"geoPoint":268,"contacts":21},"Hospital de Cruces","Barakaldo","Vizcaya","48903",{"type":57,"coordinates":265},[266,267],-2.98813,43.29639,{"lat":267,"lon":266},{"type":270,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[272],{"name":273,"class":6},"Fundacion Miguel Servet","100648071","phase-2-fractionated-stereotactic-radiotherapy-plus-second-generation-antiandrogen-for-oligometastatic-castration-resistant-prostate-cancer-patients-100648071",false,"NCT07717268","Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.","Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.","OLIGORESIST","Inclusion Criteria:\n\n* Patients with histologically prostate adenocarcinoma, confirmed with a biopsy.\n* Testosterone in biochemical castration ranges (testosterone \\\u003C50 ng\u002Fml or 1.7 nmol\u002FL) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET\u002FCT or Choline PET\u002FCT)\n* Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone \\\u003C50 ng\u002Fml or 1.7 nmol\u002FL).\n* Radiological confirmation (with choline-PET\u002FCT or 68Ga-PSMA-PET\u002FCT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (\\\u003C 3 cm major diameter in bone metastases, \\\u003C 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases.\n* Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance.\n* Patients must provide written informed consent.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* Patients with prostate carcinoma with histology other than adenocarcinoma.\n* No previous biopsy.\n* \\> 5 metastasis, not approachables in 5 treatment fields\n* Patients with visceral metastasis and or metastasis non elegible to receive SBRT.\n* Patients with Testosterone above castration levels\n* Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.","MALE",{"count":284,"type":285},51,"ESTIMATED","INTERVENTIONAL",[288],"PHASE2","The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5).\n\nHence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide).\n\nPrimary objective: Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET\u002FCT or 68Ga-PSMA PET\u002FCT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.\n\nSecondary objectives:\n\n* Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.\n* Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.\n* Acute and chronic toxicity according to the \"Common Terminology Criteria for Adverse Events\" (CTCAEv5.0) scale.\n\nThis is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC).\n\nPatients will be recruited at the participant sites, after study approval and hospital authorization.\n\n51 patients will be included in the study. Eligible patients will require:\n\n* Choline PET\u002FCT or 68Ga-PSMA PET\u002FCT, dated no more than 8 weeks prior to inclusion.\n* Clinical history, physical examination and functional evaluation scale (ECOG).\n* Geriatric assessment scale for patients \\> 75 years (modified G8 scale)\n* Toxicity scale assessment (CTCAEv5.0)\n* Baseline quality of life questionnaire (EORTC QLQ-C30) (47)\n* Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion.\n* Inclusion\u002Fexclusion criteria assessment\n* Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case.\n\nEach patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and\u002For exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and\u002For exitus.\n\nRecruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.",[291],"Prostatic Neoplasms, Castration-Resistant",[293,294,295,296,297],"Fractionated stereotactic radiotherapy","second-generation antiandrogen","Phase II","castration-resistant prostate cancer","oligometastatic patients","2026-07-16",{"date":300,"type":301},"2026-07-21","ACTUAL",{"date":303,"type":301},"2024-05-16",{"date":305,"type":285},"2030-05-16",{"name":5,"class":6},15]