[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640868":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":67,"collaborators":28,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":28,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":28,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose level 1","EXPERIMENTAL","120 mCi of 161Tb-PSMA-I\\&T every 6 weeks for 3 cycles",[13],"Drug: 161Tb-PSMA-I&T",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose level 2","150 mCi of 161Tb-PSMA-I\\&T every 6 weeks for 3 cycles",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose level 3","200 mCi of 161Tb-PSMA-I\\&T every 6 weeks for 3 cycles",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","161Tb-PSMA-I&T","161Tb-PSMA-I\\&T for injections, slow intravenous administration, 200 mCi\u002F5 mL\u002FVial",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Ching-Chu Lu","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Pei-Ju Chuang","CONTACT","+886-2-2322-0322","237966","pjchuang.ntucc@gmail.com",{"name":31,"role":36,"phone":41,"phoneExt":42,"email":43},"+886-2-2312-3456","265477","kelvinlu@ntuh.gov.tw",[45,60],{"facility":46,"status":47,"city":48,"state":28,"zip":28,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"National Taiwan University Cancer Center","RECRUITING","Taipei","Taiwan","TW",{"type":52,"coordinates":53},"Point",[54,55],121.52639,25.05306,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":37,"phoneExt":38,"email":39},"Dr. Chuang",{"facility":5,"status":47,"city":48,"state":28,"zip":28,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},{"type":52,"coordinates":62},[54,55],{"lat":55,"lon":54},[65],{"name":66,"role":36,"phone":41,"phoneExt":42,"email":43},"Dr. Lu",{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100640868","phase-1-exploring-auger-enhanced-psma-targeted-radioligand-therapy-a-first-in-taiwan-clinical-study-of-161tb-psma-it-100640868",false,"NCT07621692","Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T","Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n1. Age ≥ 20 years, ability to understand and willingness to sign informed consent, cooperate with all study-related procedures and assessments including blood tests and imaging\n2. Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)\n3. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level \\\u003C50 ng\u002FdL (castrate range)\n4. Prior treated with at least one line of taxane-based chemotherapy unless medically unsuitable, and at least one line of androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)\n5. Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient\n6. Progressive disease defined according to Prostate Cancer Clinical Trials Working Group 3: Either a PSA progression of more than 2 rising PSA values from baseline with intervals ≥ 1 week, or a soft-tissue progression on images per RECIST 1.1 criteria, or a bone progression on images with more than 2 new lesions\n7. Evidence of significant PSMA-avid lesions on 68Ga- or 18F-labeled PSMA PET\u002FCT within 12 weeks prior to screening, which defined as 68Ga-PSMA or 18F-PSMA uptake greater than that of liver or spleen parenchyma (depend on the tracer used) in at least one metastatic lesion of any size in any organ system\n8. A life expectancy of ≥ 6 months and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n9. Adequate bone marrow and organ functions 9.1 Hemoglobin ≥ 10 g\u002FdL without RBC transfusion within 4 weeks 9.2 Absolute neutrophil count ≥ 1.5 × 109\u002FL 9.3 Platelet count ≥ 150 × 109\u002FL 9.4 Creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault) 9.5 AST and ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN\n10. Willingness to comply with the use of medically acceptable forms of barrier contraception if sexually active\n\nExclusion Criteria:\n\n1. History of allergic reaction to PSMA-targeted compounds or radiometals\n2. Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months\n3. Prior surgery or radiotherapy within 4 weeks prior to first investigational dose\n4. Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi)\n5. Discordant disease on PET images: FDG-positive disease with minimal PSMA expression\n6. Urinary tract obstruction causing hydronephrosis unless appropriately treated beforehand\n7. Known symptomatic brain metastases or leptomeningeal disease, symptomatic or impending cord compression unless appropriately treated beforehand\n8. Other active malignancy requiring systemic treatment\n9. Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina)\n10. Concurrent severe uncontrolled illness that may jeopardize patient safety, including uncontrolled infections","MALE","20 Years",{"count":79,"type":80},12,"ESTIMATED","INTERVENTIONAL",[83],"PHASE1","This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.",[86],"Metastatic Castration Resistant Prostate Cancer (mCRPC)",[88,89,90,86],"Radioligand therapy","Terbium-161","Prostate-specific Membrane Antigen (PSMA)","2026-05-29",{"date":93,"type":94},"2026-06-02","ACTUAL",{"date":96,"type":94},"2026-01-01",{"date":98,"type":80},"2030-12-31",{"name":5,"class":6},2]