[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556929":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":270,"collaborators":27,"id":272,"slug":273,"hasResults":274,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":274,"sex":280,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":27,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":46,"whyStopped":27,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AAA617","EXPERIMENTAL","All participants will receive the investigational product AAA617 (7.4 GBq ±10%).",[13,14,15],"Drug: AAA617","Drug: 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5PT","United Kingdom","UK",{"type":53,"coordinates":249},[250,251],-0.2,51.35,{"lat":251,"lon":250},{"facility":131,"status":46,"city":254,"state":255,"zip":256,"country":246,"countryCode":247,"cosmosGeoPoint":257,"geoPoint":261,"contacts":27},"Birmingham","West Midlands","B15 2TH",{"type":53,"coordinates":258},[259,260],-1.89983,52.48142,{"lat":260,"lon":259},{"facility":131,"status":46,"city":263,"state":27,"zip":264,"country":246,"countryCode":247,"cosmosGeoPoint":265,"geoPoint":269,"contacts":27},"Glasgow","G12 0YN",{"type":53,"coordinates":266},[267,268],-4.25763,55.86515,{"lat":268,"lon":267},{"type":271,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100556929","phase-1-a-study-of-radiation-dosimetry-safety-and-tolerability-of-extended-lutetium-177lu-vipivotide-tetraxetan-treatment-in-chemo-nave-adults-with-metastatic-castration-resistant-prostate-cancer-radiopharmaceutical-dosimetry-evaluation-radiodose-study-100556929",false,"NCT06531499","A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study","A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer","RADIODOSE","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status ≤ 1.\n* Participants must have histological confirmation of adenocarcinoma of the prostate.\n* Participants must be PSMA-positive per 68Ga-PSMA PET\u002FCT scans at baseline\n* Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL) either by pharmaceutical or surgical methods.\n* Participants must have progressed only once on prior second generation ARPIs\n* Documented progressive mCRPC\n* Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening\u002Fbaseline CT, MRI, or bone scan\n* Renal: eGFR ≥ 60 mL\u002Fmin\u002F1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.\n\nKey exclusion Criteria:\n\n* Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation\n* Any previous radioligand therapy.\n* Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \\[including monoclonal antibodies\\]. \\[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\\].\n* Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy\n* History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and\u002For clinically active significant cardiac disease\n* Concurrent serious acute or chronic nephropathy and\u002For moderate to severe renal impairment as determined by the principal investigator.\n* Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment\n* Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.\n* Concurrent urinary outflow obstruction or unmanageable urinary incontinence\n* History of somatic or psychiatric disease\u002Fcondition that may interfere with the aims and assessments of the study.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","18 Years","100 Years",{"count":284,"type":285},106,"ESTIMATED","INTERVENTIONAL",[288],"PHASE1","The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \\[177Lu\\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml\u002Fmin).",[291],"Metastatic Castration-Resistant Prostate Cancer",[293,278,9,294,295,296,297,298,299,300,301,302,303,304],"Phase 1","metastatic castration-resistant prostate cancer","radiation dosimetry","mCRPC","Prostate-specific membrane antigen (PSMA)","Dosimetry","[68Ga]Ga-PSMA-11","gallium (68Ga) gozetotide","[177Lu]Lu-PSMA-617","lutetium (177Lu) vipivotide tetraxetan","Radioligand Imaging (RLI)","Radioligand Therapy (RLT)","2025-12-29",{"date":307,"type":308},"2025-12-31","ACTUAL",{"date":310,"type":308},"2024-11-11",{"date":312,"type":285},"2028-11-24",{"name":34,"class":6},21]