[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596956":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":24,"responsibleParty":297,"collaborators":299,"id":303,"slug":304,"hasResults":305,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":311,"sex":312,"minAge":313,"maxAge":23,"enrollmentInfo":314,"targetDuration":23,"studyType":317,"phases":318,"briefSummary":320,"conditions":321,"keywords":331,"overallStatus":27,"whyStopped":23,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},{"fullName":5,"class":6},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Illuccix: 68Ga-PSMA-11\u002FGallium Ga 68 Gozetotide","OTHER","This is a single arm study. All participants will first undergo mpMRI and PSMA PET scans (one single IV bolus of Gallium Ga 68 Gozetotide administered)",[13],"Drug: 68Ga-PSMA-11",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","68Ga-PSMA-11","The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \\[2-hydroxy-5-(carboxyethyl)benzyl\\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET.",[9],[21,22],"Illuccix","Gallium Ga 68 Gozetotide",null,[25,45,59,74,88,103,118,133,147,162,176,188,203,218,232,247,262,282],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"University of California Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-118.24368,34.05223,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":23,"email":44},"Ankush Sachdeva","CONTACT","310-794-3452","asachdeva@mednet.ucla.edu",{"facility":46,"status":27,"city":47,"state":29,"zip":48,"country":31,"countryCode":32,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"University of California San Francisco","San Francisco","94158",{"type":34,"coordinates":50},[51,52],-122.41942,37.77493,{"lat":52,"lon":51},[55],{"name":56,"role":42,"phone":57,"phoneExt":23,"email":58},"An Nguyen","510-545-9040","an.nguyen5@ucsf.edu",{"facility":60,"status":27,"city":61,"state":62,"zip":63,"country":31,"countryCode":32,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Impression Imaging","Boca Raton","Florida","33433",{"type":34,"coordinates":65},[66,67],-80.0831,26.35869,{"lat":67,"lon":66},[70],{"name":71,"role":42,"phone":72,"phoneExt":23,"email":73},"Jessica Myers","352-525-5760","jessica.myers@milestoneone.com",{"facility":75,"status":27,"city":76,"state":62,"zip":77,"country":31,"countryCode":32,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University of Miami","Miami","33136",{"type":34,"coordinates":79},[80,81],-80.19366,25.77427,{"lat":81,"lon":80},[84],{"name":85,"role":42,"phone":86,"phoneExt":23,"email":87},"Elena Cortizas","305-243-3593","ecortizas@med.miami.edu",{"facility":89,"status":27,"city":90,"state":91,"zip":92,"country":31,"countryCode":32,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"UroPartners,LLC","Chicago","Illinois","60657",{"type":34,"coordinates":94},[95,96],-87.65005,41.85003,{"lat":96,"lon":95},[99],{"name":100,"role":42,"phone":101,"phoneExt":23,"email":102},"Kelly Liberatore","610-667-0458","kliberatore@midlanticurology.com",{"facility":104,"status":27,"city":105,"state":106,"zip":107,"country":31,"countryCode":32,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Indiana University","Indianapolis","Indiana","46202",{"type":34,"coordinates":109},[110,111],-86.15804,39.76838,{"lat":111,"lon":110},[114],{"name":115,"role":42,"phone":116,"phoneExt":23,"email":117},"Ashley Frazee","317-278-4959","amfrazee@iu.edu",{"facility":119,"status":27,"city":120,"state":121,"zip":122,"country":31,"countryCode":32,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Southern Urology","Lafayette","Louisiana","70508",{"type":34,"coordinates":124},[125,126],-92.01984,30.22409,{"lat":126,"lon":125},[129],{"name":130,"role":42,"phone":131,"phoneExt":23,"email":132},"Simone Olivier","337-422-3770","solivier@ssmsla.com",{"facility":134,"status":27,"city":135,"state":121,"zip":136,"country":31,"countryCode":32,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Ochsner Clinic Foundation","New Orleans","70121",{"type":34,"coordinates":138},[139,140],-90.07507,29.95465,{"lat":140,"lon":139},[143],{"name":144,"role":42,"phone":145,"phoneExt":23,"email":146},"Rachel Graham","504-842-2961","rgraham@ochsner.org",{"facility":148,"status":27,"city":149,"state":150,"zip":151,"country":31,"countryCode":32,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Washington University","St Louis","Missouri","63110",{"type":34,"coordinates":153},[154,155],-90.19789,38.62727,{"lat":155,"lon":154},[158],{"name":159,"role":42,"phone":160,"phoneExt":23,"email":161},"Megan Luther","314-747-2012","lutherm@wustl.edu",{"facility":163,"status":27,"city":164,"state":164,"zip":165,"country":31,"countryCode":32,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Weill Cornell","New York","10065",{"type":34,"coordinates":167},[168,169],-74.00597,40.71427,{"lat":169,"lon":168},[172],{"name":173,"role":42,"phone":174,"phoneExt":23,"email":175},"Alexis Watson","646-962-2347","alw4020@med.cornell.edu",{"facility":177,"status":27,"city":178,"state":179,"zip":180,"country":31,"countryCode":32,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"MidLantic Urology","Philadelphia","Pennsylvania","19004",{"type":34,"coordinates":182},[183,184],-75.16362,39.95238,{"lat":184,"lon":183},[187],{"name":100,"role":42,"phone":101,"phoneExt":23,"email":102},{"facility":189,"status":27,"city":190,"state":191,"zip":192,"country":31,"countryCode":32,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Atlantic Urology Specialists","Myrtle Beach","South Carolina","29572",{"type":34,"coordinates":194},[195,196],-78.88669,33.68906,{"lat":196,"lon":195},[199],{"name":200,"role":42,"phone":201,"phoneExt":23,"email":202},"Crystal Mitchell","843-449-1010","crystal.mitchell@startresearch.com",{"facility":204,"status":27,"city":205,"state":206,"zip":207,"country":31,"countryCode":32,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"The Conrad Pearson Clinic","Germantown","Tennessee","38138",{"type":34,"coordinates":209},[210,211],-89.81009,35.08676,{"lat":211,"lon":210},[214],{"name":215,"role":42,"phone":216,"phoneExt":23,"email":217},"Russell Gribsby","901-236-0957","russell.grigsby@conradpearson.com",{"facility":219,"status":27,"city":220,"state":206,"zip":221,"country":31,"countryCode":32,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Urology Associates of Nashville","Nashville","37209",{"type":34,"coordinates":223},[224,225],-86.78444,36.16589,{"lat":225,"lon":224},[228],{"name":229,"role":42,"phone":230,"phoneExt":23,"email":231},"Rick Trotter","615-250-9268","CRTrotter@ua-pc.com",{"facility":233,"status":27,"city":234,"state":235,"zip":236,"country":31,"countryCode":32,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Urology Austin","Austin","Texas","78759",{"type":34,"coordinates":238},[239,240],-97.74306,30.26715,{"lat":240,"lon":239},[243],{"name":244,"role":42,"phone":245,"phoneExt":23,"email":246},"Christine Chau","512-410-3773","christine.chau@urologyaustin.com",{"facility":248,"status":27,"city":249,"state":250,"zip":251,"country":31,"countryCode":32,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Urology of Virginia","Virginia Beach","Virginia","23462",{"type":34,"coordinates":253},[254,255],-75.97799,36.85293,{"lat":255,"lon":254},[258],{"name":259,"role":42,"phone":260,"phoneExt":23,"email":261},"Julia Csenar","(757) 452-3463","jcsenar@urologyofva.net",{"facility":263,"status":27,"city":264,"state":265,"zip":266,"country":267,"countryCode":268,"cosmosGeoPoint":23,"geoPoint":23,"contacts":269},"Australian Prostate Centre","Melbourne N.","Victoria","3055","Australia","AU",[270,274,277,280],{"name":271,"role":42,"phone":272,"phoneExt":23,"email":273},"Rachel Heerey","+61 (03) 8373 7600","info@apcr.org.au",{"name":275,"role":276,"phone":23,"phoneExt":23,"email":23},"Professor Anthony Costello, Urologist","PRINCIPAL_INVESTIGATOR",{"name":278,"role":279,"phone":23,"phoneExt":23,"email":23},"Mr Phillip Dundee, Urology Surgeon","SUB_INVESTIGATOR",{"name":281,"role":279,"phone":23,"phoneExt":23,"email":23},"Professor Rodney Hicks",{"facility":283,"status":27,"city":284,"state":23,"zip":23,"country":267,"countryCode":268,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"St Vincent's Hospital Sydney","Sydney",{"type":34,"coordinates":286},[287,288],151.20732,-33.86785,{"lat":288,"lon":287},[291,295],{"name":292,"role":42,"phone":293,"phoneExt":23,"email":294},"Shraddha Weir","+61 2 8382 1807","shraddha.weir@svha.org.au",{"name":296,"role":276,"phone":23,"phoneExt":23,"email":23},"Professor Louise Emmett",{"type":298,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[300],{"name":301,"class":302},"Telix Innovations S.A.","UNKNOWN","100596956","phase-3-psma-pet-combined-with-mri-for-the-detection-of-pca-100596956",false,"NCT07052214","PSMA PET Combined With MRI for the Detection of PCa","A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).","BiPASS","Inclusion Criteria:\n\n1. Male, at least 18 years old.\n2. Have a clinical suspicion of csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and\u002For have non-imaging risk factors (including but not exclusive to):\n\n   a) Persistently elevated or rising PSA b) High PSA density c) Abnormal digital rectal examination (DRE) d) Strong family history of prostate cancer: i. First-degree relative (father or brother) with csPCa ii. Any relative diagnosed at \\\u003C65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g. BReast CAncer gene \\[BRCA\\]1\u002F2, Homeobox protein Hox-B13 \\[HOXB13\\] mutations) e) Other high-risk biomarkers: i. 4Kscore ii. PHI (Prostate Health Index) iii. High Prostate Cancer Antigen 3 (PCA3) iv. Any other established biomarker with values in the high-risk range f) Clinical presentation: i. Symptoms suggestive of locally advanced disease (e.g. urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern\n3. Prostate biopsy naïve.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines.\n5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements.\n6. Provides consent for anatomical template with\u002Fwithout targeted biopsy based on clinical risk, MRI and PSMA PET result.\n7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.\n8. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \\[Clinical Trial Facilitation Group\\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has prior diagnosis of csPCa\n2. Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).\n\n4\\. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.\n\n5\\. Prior pelvic irradiation 6. Demonstrate radiographic findings of PI-RADS 5. 7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and\u002For is deemed not suitable for participating in this trial in the opinion of the investigator.\n\n8\\. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator. 9. Is unable to attain or remain in a supine position while a PET\u002FCT scan is being performed or unable to tolerate a PET\u002FCT scan 10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug\u002Fcomparator or its excipients.\n\n11\\. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.\n\n12\\. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens\u002Finterventions would be deemed eligible to enroll.",true,"MALE","18 Years",{"count":315,"type":316},338,"ESTIMATED","INTERVENTIONAL",[319],"PHASE3","This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).",[322,323,324,325,326,327,328,329,330],"PCA","Prostate Cancer","Prostatic Neoplasm","PSMA PET","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Prostate Biopsy","Carcinoma of the Prostate",[332,333,334,335,336,337,338,339],"Molecular Imaging","Biopsy Naive","Magnetic Resonance Imaging","Biopsy","Targeted Biopsy","Radiopharmaceuticals","Cancer Detection","Urologic Oncology","2026-07-22",{"date":342,"type":343},"2026-07-23","ACTUAL",{"date":345,"type":343},"2025-08-18",{"date":347,"type":316},"2027-04",{"name":5,"class":6},18]