[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482332":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":41,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":12,"enrollmentInfo":103,"targetDuration":12,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":12,"overallStatus":44,"whyStopped":12,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Peter MacCallum Cancer Centre, Australia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic ablative body radiotherapy (SABR) alone","NO_INTERVENTION","1-3 fractions of SABR to all sites of disease",null,{"label":14,"type":15,"description":16,"interventionNames":17},"SABR plus 2 cycles of 177Lu-PSMA","EXPERIMENTAL","cycles of 177Lu-PSMA with 1-3 fractions of SABR to all sites of disease between cycle 1 and 2",[18],"Drug: 177Lu-PSMA",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","177Lu-PSMA","Lutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Numerous retrospective series initially demonstrated high clinical activity and limited normal tissue toxicity using PSMA-617 and PSMA-I\\&T, which are the most advanced small molecule inhibitors of PSMA, radiolabelled with 177Lu",[14],[26,29],{"name":27,"affiliation":5,"role":28},"A\u002FProf. Shankar Siva","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Dr Aravind S. Ravi Kumar",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":12,"email":36},"Gaurav Sharma","CONTACT","+61 3 8559 6830","Gaurav.Sharma@petermac.org",{"name":38,"role":34,"phone":39,"phoneExt":12,"email":40},"Annette VanDerHeyden","+61488048792","Annette.VanDerHeyden@petermac.org",[42,60,73],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Royal North Shore","RECRUITING","St Leonards","New South Wales","2065","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.19836,-33.82344,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":12,"phoneExt":12,"email":59},"Thomas Eade","thomas.eade@health.nsw.gov.au",{"facility":61,"status":44,"city":62,"state":63,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"type":51,"coordinates":66},[67,68],144.96332,-37.814,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":12,"phoneExt":12,"email":12},"Shankar Siva, MBBS FRANZCR",{"facility":74,"status":44,"city":75,"state":12,"zip":12,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Sheba Medical Centre","Tel Aviv","Israel","IL",{"type":51,"coordinates":79},[80,81],34.78057,32.08088,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":12,"phoneExt":12,"email":86},"Michal Safarty","Michal.sarfaty@sheba.health.gov.il",{"type":88,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[90],{"name":91,"class":92},"Varian Medical Systems","INDUSTRY","100482332","phase-2-lu-psma-for-oligometastatic-prostate-cancer-treated-with-stereotactic-ablative-radiotherapy-100482332",false,"NCT05560659","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial","POPSTAR II","Inclusion Criteria:\n\n1. Male aged 18 years or older at screening\n2. Patient has provided written informed consent\n3. Histologically confirmed prostate adenocarcinoma w\n4. Prior definitive treatment of the primary with either curative intent radiotherapy and\u002For surgery\n5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET\u002FCT\n6. Adequate haematological function as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n   * Platelet count \\>150x 109\u002FL\n   * Haemoglobin ≥100 g\u002FL\n   * Creatinine Clearance ≥ 40mL\u002Fmin (Cockcroft-Gault formula)\n7. Assessed as suitable for SABR by a radiation oncologist\n8. Patients must agree to use an adequate method of contraception\n9. Have a performance status of 0-1 on the ECOG Performance Scale\n\nExclusion Criteria:\n\n1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal\n2. Any visceral (AJCCC M1c) metastases\n3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n5. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.","MALE","18 Years",{"count":104,"type":105},92,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.",[111],"Oligometastatic Prostate Cancer","2025-07-08",{"date":114,"type":115},"2025-07-11","ACTUAL",{"date":117,"type":115},"2023-12-14",{"date":119,"type":105},"2027-05",{"name":5,"class":6},3]