[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504364":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":31,"locations":32,"responsibleParty":145,"collaborators":147,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":31,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":31,"enrollmentInfo":159,"targetDuration":31,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":31,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (68Ga-PSMA-11)","EXPERIMENTAL","111 \\~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes.\n\nAfter 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET\u002FCT or PET\u002FMRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.",[13,14],"Drug: 68Ga-PSMA-11","Other: PET\u002FCT or PET\u002FMRI",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","68Ga-PSMA-11","A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes",[9],[22,23],"Illucix","gallium Ga 68 Gozetotide",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"OTHER","PET\u002FCT or PET\u002FMRI","PET\u002FCT or PET\u002FMRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11",[9],[30],"Imaging by PET",null,[33,54,67,80,93,109,122,132],{"facility":34,"status":35,"city":36,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Peking University First Hospital","RECRUITING","Beijing","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Principal Investigator","CONTACT","0086-010-83572732","info@telixpharma.com",{"name":52,"role":53,"phone":31,"phoneExt":31,"email":31},"Yan Fan","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":35,"city":56,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Xiangya Hospital Central South University","Changsha",{"type":40,"coordinates":58},[59,60],112.97087,28.19874,{"lat":60,"lon":59},[63,65],{"name":47,"role":48,"phone":64,"phoneExt":31,"email":50},"0086-0731-89752051",{"name":66,"role":53,"phone":31,"phoneExt":31,"email":31},"Shuo Hu",{"facility":68,"status":35,"city":69,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Nanfang Hospital Southern Medical University","Guangzhou",{"type":40,"coordinates":71},[72,73],113.25,23.11667,{"lat":73,"lon":72},[76,78],{"name":47,"role":48,"phone":77,"phoneExt":31,"email":50},"0086-020-62783210",{"name":79,"role":53,"phone":31,"phoneExt":31,"email":31},"Wanlong Tan",{"facility":81,"status":35,"city":82,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Fudan University Shanghai Cancer Center","Shanghai",{"type":40,"coordinates":84},[85,86],121.45806,31.22222,{"lat":86,"lon":85},[89,91],{"name":47,"role":48,"phone":90,"phoneExt":31,"email":50},"0086-021-64175590-88900",{"name":92,"role":53,"phone":31,"phoneExt":31,"email":31},"Shaoli Song",{"facility":94,"status":35,"city":95,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"West China Hospital of Sichuan University","Sichuan",{"type":40,"coordinates":97},[98,99],105.48032,35.1221,{"lat":99,"lon":98},[102,104,106],{"name":47,"role":48,"phone":103,"phoneExt":31,"email":50},"0086-028-85423532",{"name":105,"role":53,"phone":31,"phoneExt":31,"email":31},"Lin Li",{"name":107,"role":108,"phone":31,"phoneExt":31,"email":31},"Pengfei Shen","SUB_INVESTIGATOR",{"facility":110,"status":35,"city":111,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Wuhan Union Hospital","Wuhan",{"type":40,"coordinates":113},[114,115],114.26667,30.58333,{"lat":115,"lon":114},[118,120],{"name":47,"role":48,"phone":119,"phoneExt":31,"email":50},"0086-027-83692633",{"name":121,"role":53,"phone":31,"phoneExt":31,"email":31},"Xiaoli Lan, PhD",{"facility":123,"status":35,"city":111,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Zhongnan Hospital of Wuhan University",{"type":40,"coordinates":125},[114,115],{"lat":115,"lon":114},[128,130],{"name":47,"role":48,"phone":129,"phoneExt":31,"email":50},"0086-027-67813181",{"name":131,"role":53,"phone":31,"phoneExt":31,"email":31},"Yong He",{"facility":133,"status":35,"city":134,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Affiliated Hosptial of Jiangnan University","Wuxi",{"type":40,"coordinates":136},[137,138],120.28857,31.56887,{"lat":138,"lon":137},[141,143],{"name":47,"role":48,"phone":142,"phoneExt":31,"email":50},"0086-0510-68089397",{"name":144,"role":53,"phone":31,"phoneExt":31,"email":31},"ChunJing Yu",{"type":146,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[148],{"name":149,"class":25},"Grand Pharmaceutical (China) Co., Ltd.","100504364","phase-3-68ga-psma-11-efficacy-in-detecting-bcr-prostate-cancer-in-chinese-patients-100504364",false,"NCT05847348","68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients","A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET\u002FCT or PET\u002FMRI in Patients With Biochemical Recurrent Prostate Cancer","Inclusion Criteria:\n\n1. Are able to understand and provide written informed consent document.\n2. Are Chinese males aged ≥ 18 years.\n3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and\u002For radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).\n\n   1. Post radical prostatectomy (RP) PSA ≥0.2 ng\u002FmL measured 6 weeks after RP\n   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng\u002FmL rise in PSA;\n4. Have a Karnofsky performance status ≥ 60 (or ECOG\u002FWHO equivalent).\n5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.\n6. Are willing and able to comply with scheduled\n\nExclusion Criteria:\n\n1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.\n2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.\n3. Are participating or plan to participate in any drug or device clinical study during the study period.\n4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.\n5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.\n6. Have prior history of salivary gland disease or Paget's disease.\n7. Have a history of fracture and anemia within the last year.\n8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.\n9. Is deemed not suitable for participating in this trial in the opinion of the investigator.","MALE","18 Years",{"count":160,"type":161},110,"ESTIMATED","INTERVENTIONAL",[164],"PHASE3","This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET\u002FCT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.",[167,168,169],"Biochemical Recurrence of Malignant Neoplasm of Prostate","Prostate Cancer","BCR Prostate Carcinoma","2024-06-29",{"date":172,"type":173},"2024-07-03","ACTUAL",{"date":175,"type":173},"2023-07-19",{"date":177,"type":161},"2026-07-30",{"name":5,"class":6},8]