[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585843":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":19,"enrollmentInfo":63,"targetDuration":19,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"St Vincent's Hospital, Sydney","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"64Cu-SAR-bisPSMA","EXPERIMENTAL","200MBq 64Cu-SAR-bisPSMA",[13],"Drug: 64Cu-SAR-bisPSMA",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Sobia Khan, MBBS, FRACP","CONTACT","+61 0283821830","svhs.nm@svha.org.au",{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},"Louise Emmett, MBChB, FRACP, MD, FAANMS","louise.emmett@svha.org.au",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Darlinghurst","New South Wales","2010","Australia","AU",{"type":38,"coordinates":39},"Point",[40,41],151.21925,-33.87939,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":24,"phoneExt":19,"email":28},"Director of Theranostics and Nuclear Medicine",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Louise Emmett","Professor",[51],{"name":52,"class":53},"Clarity Pharmaceuticals Ltd","INDUSTRY","100585843","phase-2-comparative-performance-of-64copper-64cu-sar-bis-psma-vs-68ga-psma-11-pet-ct-for-the-detection-of-prostate-cancer-recurrence-in-the-setting-of-biochemical-failure-following-radical-prostatectomy-100585843",false,"NCT06907641","Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy","Co-PSMA","Inclusion Criteria:\n\n* Male patients aged 18 or above\n* Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.\n* Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.\n* Rising PSA (0.20 - 0.75 ng\u002FmL) following radical prostatectomy with no prior salvage radiotherapy.\n* 68Ga PSMA-11 PET\u002FCT within the last 4 weeks for prostate cancer biochemical recurrence.\n\nExclusion Criteria:\n\n* Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.\n* History of current active malignancy as per investigator discretion other than prostate cancer.\n* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA\n* Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.","MALE","18 Years",{"count":64,"type":65},50,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET\u002FCT and 68Ga PSMA-11 PET\u002FCT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:\n\n* Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET\u002FCT and 68Ga PSMA-11 PET\u002FCT scans.\n* What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET\u002FCT compared to 68Ga PSMA-11 PET\u002FCT using a standard of care comparator.\n* Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).\n\nParticipants will:\n\n* have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET\u002FCT scan; 2) 64Cu-SAR-bisPSMA dose and PET\u002FCT; 3) 64Cu-SAR-bisPSMA PET\u002FCT only\n* have standard of care blood test either at Visit 1 or Visit 2",[71],"Prostate Cancer (Post Prostatectomy)",[73,74,75,59,76,77,78,79,80,81],"Prostate Cancer","Salvage Radiotherapy","Prostatectomy","CLP11","Prostate Cancer Recurrence","Biochemical Failure","Radical Prostatectomy","Copper","PET scan","2025-04-01",{"date":84,"type":85},"2025-04-02","ACTUAL",{"date":87,"type":85},"2024-11-21",{"date":89,"type":65},"2025-11",{"name":5,"class":6},1]