[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550646":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":50,"overallOfficials":30,"centralContacts":58,"locations":68,"responsibleParty":90,"collaborators":30,"id":92,"slug":30,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":30,"enrollmentInfo":101,"targetDuration":30,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":30,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment effectiveness","Assessment of treatment failure - the assesment of biochemical progression ratio, defined as a rise of PSA by 2 ng\u002FmL or more above the nadir, proven by a consecutive examination performed at least 4 weeks later","2 and 5 years after end of treatment",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Biochemical progression-free survival","Comparative assessment of biochemical progression-free survival time defined as an increase in tPSA (prostate specific antigen) in the blood above the nadir (the lowest PSA value after completion of treatment) by 2 ng\u002FmL or more, confirmed in the next test performed no earlier than after 4 weeks","During the intervention and follow up period (assessed up to 5 years)",{"measure":19,"description":20,"timeFrame":17},"Radiological progression-free survival","Comparative assessment of radiological progression-free survival defined according to PCWG3 criteria",{"measure":22,"description":23,"timeFrame":17},"Time until the next therapeutic intervention","Comparative assessment of the time until the next therapeutic intervention",{"measure":25,"description":26,"timeFrame":17},"Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0","Comparative assessment of safety and tolerability of treatment according to CTCAE v 5.0",{"measure":28,"description":29,"timeFrame":17},"Quliaty of life","Comparison of EORTC QLQ-PR25 quality of life indicators between study groups",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Open-label, two-arm, randomized study.","TREATMENT",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.\n\nThe study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy\n\nParticipation time in the Study:\n\nintervention phase - 1 day; observation phase - 5 years",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"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",[45],"Drug: Lutetium (177Lu) vipivotide tetraxetan",{"label":47,"type":48,"description":49,"interventionNames":30},"Control","NO_INTERVENTION","Participants will receive standard hormone therapy",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","Lutetium (177Lu) vipivotide tetraxetan","The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan",[41],[57],"Pluvicto",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":30,"email":63},"Daria Handkiewicz-Junak","CONTACT","48322789339","daria.handkiewicz-junak@gliwice.nio.gov.pl",{"name":65,"role":61,"phone":66,"phoneExt":30,"email":67},"Agnieszka Ciomber","48322789797","agnieszka.ciomber@gliwice.nio.gov.pl",[69],{"facility":70,"status":71,"city":72,"state":30,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch","RECRUITING","Gliwice","44-101","Poland","PL",{"type":77,"coordinates":78},"Point",[79,80],18.67658,50.29761,{"lat":80,"lon":79},[83,87],{"name":84,"role":61,"phone":85,"phoneExt":30,"email":86},"Tomasz Lachcik","+48322789791","tomasz.lachcik@gliwice.nio.gov.pl",{"name":88,"role":89,"phone":30,"phoneExt":30,"email":30},"Daria Handkiewicz-Junak, Prof.","PRINCIPAL_INVESTIGATOR",{"type":91,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":102,"type":103},200,"ESTIMATED","INTERVENTIONAL",[106],"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",[109],"Prostate Cancer","2025-02-05",{"date":112,"type":113},"2025-02-10","ACTUAL",{"date":115,"type":113},"2025-01-09",{"date":117,"type":103},"2030-11",{"name":5,"class":6},1]