[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550646":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":37,"responsibleParty":59,"collaborators":18,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","The intervention will consist of a single administration of 177Lu-PSMA with an activity of 7.4 GBq. Participants will also receive standard hormone therapy",[13],"Drug: Lutetium (177Lu) vipivotide tetraxetan",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants will receive standard hormone therapy",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Lutetium (177Lu) vipivotide tetraxetan","The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan",[9],[26],"Pluvicto",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Daria Handkiewicz-Junak","CONTACT","48322789339","daria.handkiewicz-junak@gliwice.nio.gov.pl",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Agnieszka Ciomber","48322789797","agnieszka.ciomber@gliwice.nio.gov.pl",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch","RECRUITING","Gliwice","44-101","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],18.67658,50.29761,{"lat":49,"lon":48},[52,56],{"name":53,"role":30,"phone":54,"phoneExt":18,"email":55},"Tomasz Lachcik","+48322789791","tomasz.lachcik@gliwice.nio.gov.pl",{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Daria Handkiewicz-Junak, Prof.","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100550646","phase-2-177lu-psma-as-a-systemic-adjuvant-treatment-in-patients-with-high-and-very-high-risk-prostate-cancer-100550646",false,"NCT06449781","177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer","177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy","PSMA-ADJUVO","Inclusion Criteria:\n\n* Giving a written informed consent\n* Histopathologically confirmed high or very high risk prostate cancer\n* Completion of radical locoregional treatment\n* Completion of locoregional treatment within 3 months before inclusion to the study\n* ECOG performance status 0 to 2\n* Age over 18 years\n* Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests\n* Castrate testosterone level (testosteron \\\u003C 50 ng\u002FdL lub 1,7 nmol\u002FL)\n* Patients with adequate function of main organs:\n\n  * bone marrow:\n\n    * neutrophils \\> 1500x10\\^9\u002FL;\n    * thrombocytes \\> 100,000x10\\^9\u002FL;\n    * hemoglobin \\> 9 g\u002FdL\n  * liver:\n\n    * bilirubin \\\u003C 2xULN (upper limit of normal) in patients with Gilbert's syndrome \\\u003C 5xULN;\n    * aminotransferase \\\u003C 3xULN\n  * kidneys:\n\n    * eGFR \\> 50 ml\u002Fmin\n    * albumin \\>2.5 mg\u002Fml\n* For men of reproductive age: the need to use double barrier contraception\n\nExclusion Criteria:\n\n* The presence of distant metastases confirmed by radiological examination\n* Absence of approval to use effective contraception method\n* Absence of Patient's consent to participate in the Study\n* Urinary tract obstruction or\u002Fand hydronephrosis.\n* Concurrent anticancer treatment.","MALE","18 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy",[79],"Prostate Cancer","2025-02-05",{"date":82,"type":83},"2025-02-10","ACTUAL",{"date":85,"type":83},"2025-01-09",{"date":87,"type":73},"2030-11",{"name":5,"class":6},1]