[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07052214":3,"trial-entities:NCT07052214":313,"trial-summary:NCT07052214":321},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":28,"study_type":37,"primary_purpose":38,"phases":39,"enrollment_info":41,"interventions":44,"primary_outcomes":54,"secondary_outcomes":62,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":309,"overall_officials":310,"references":311,"see_also_links":312},"NCT07052214","68Ga-TLX007-CDx-301","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).","RECRUITING","2027-04","2026-07","2026-07-23","2025-08-18","Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",false,"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).","This is a single arm, multicenter, prospective, open label Phase 3 study with PSMA PET for the detection of PCa. A total of 338 participants will be enrolled from approximately 25 investigative sites in the United States and Australia.\n\nParticipants with a clinical suspicion of PCa, who will undergo template biopsy, based on initial MRI (PI-RADs 3-4) within 6 months before enrollment and\u002For based on clinical suspicion (for PI-RADs 1-2) and who have never undergone a prostate biopsy will be eligible for the study. All participants will first undergo MRI and PSMA PET scans, followed by standard 12 core anatomical (2 core six sectors) template biopsy. If the patient does not have a biopsy, at the discretion of clinician, they'll be followed up at 6month visit. If additional lesions are detected on MRI and\u002For PSMA PET, MRI and\u002For PMSA PET targeted biopsy can be performed (according to clinician judgment).\n\nBoth MRI and\u002For PSMA targeted biopsies will be performed with 2 cores per lesion or as per institutional standards. Clinicians may use PSMA PET to rule out the need for biopsy, in which case, the patient will not have a histopathological SOT and will need to be followed up at 6 months. All biopsy and clinical care decisions are at the discretion of the investigator\u002Fclinician (i.e. the clinician may decide to: not biopsy, solely template biopsy, additional targeted biopsies, etc.) Participants presenting with csPCa will undergo therapy\u002Fmanagement as per institutional standard, or according to clinician judgment.\n\nFollow-up data will be collected for up to 6-months for participants (participants with no baseline imaging or histopathological evidence of PCa). Additional imaging, template and\u002For targeted biopsies may be performed during the follow-up period, at the discretion of the investigator. Any additional biopsy, imaging, clinical, histological, genetic, and intervention data will contribute to the determination of the CSOT. Follow-up will provide longitudinal surveillance to ensure that participants initially evaluated as negative for PCa on both imaging and histopathology are reliably negative.",[19,20,21,22,23,24,25,26,27],"PCA","Prostate Cancer","Prostatic Neoplasm","PSMA PET","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Prostate Biopsy","Carcinoma of the Prostate",[29,30,31,32,33,34,35,36],"Molecular Imaging","Biopsy Naive","Magnetic Resonance Imaging","Biopsy","Targeted Biopsy","Radiopharmaceuticals","Cancer Detection","Urologic Oncology","INTERVENTIONAL","DIAGNOSTIC",[40],"PHASE3",{"count":42,"type":43},338,"ESTIMATED",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":51},"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.",[50],"Illuccix: 68Ga-PSMA-11\u002FGallium Ga 68 Gozetotide",[52,53],"Illuccix","Gallium Ga 68 Gozetotide",[55,59],{"measure":56,"description":57,"timeFrame":58},"Primary Objective","To evaluate the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI targeted biopsy for the detection of PCa, using histopathological confirmation as the SOT.","12 months",{"measure":60,"description":61,"timeFrame":58},"Co-Primary Endpoint","To assess the sensitivity and specificity of 68Ga-PSMA-11 PET as adjunct to MRI or the detection of PCa, confirmed by predefined standard of truth (SOT).",[],"MALE","18 Years",null,true,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"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.",[72,73],"ADULT","OLDER_ADULT",[75,90,102,115,127,140,153,166,178,191,203,213,226,239,251,264,277,296],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"University of California Los Angeles","Los Angeles","California","90095","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Ankush Sachdeva","CONTACT","310-794-3452","asachdeva@mednet.ucla.edu",{"lat":88,"lon":89},34.05223,-118.24368,{"facility":91,"status":8,"city":92,"state":78,"zip":93,"country":80,"contacts":94,"geoPoint":99},"University of California San Francisco","San Francisco","94158",[95],{"name":96,"role":84,"phone":97,"email":98},"An Nguyen","510-545-9040","an.nguyen5@ucsf.edu",{"lat":100,"lon":101},37.77493,-122.41942,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":80,"contacts":107,"geoPoint":112},"Impression Imaging","Boca Raton","Florida","33433",[108],{"name":109,"role":84,"phone":110,"email":111},"Jessica Myers","352-525-5760","jessica.myers@milestoneone.com",{"lat":113,"lon":114},26.35869,-80.0831,{"facility":116,"status":8,"city":117,"state":105,"zip":118,"country":80,"contacts":119,"geoPoint":124},"University of Miami","Miami","33136",[120],{"name":121,"role":84,"phone":122,"email":123},"Elena Cortizas","305-243-3593","ecortizas@med.miami.edu",{"lat":125,"lon":126},25.77427,-80.19366,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":80,"contacts":132,"geoPoint":137},"UroPartners,LLC","Chicago","Illinois","60657",[133],{"name":134,"role":84,"phone":135,"email":136},"Kelly Liberatore","610-667-0458","kliberatore@midlanticurology.com",{"lat":138,"lon":139},41.85003,-87.65005,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":80,"contacts":145,"geoPoint":150},"Indiana University","Indianapolis","Indiana","46202",[146],{"name":147,"role":84,"phone":148,"email":149},"Ashley Frazee","317-278-4959","amfrazee@iu.edu",{"lat":151,"lon":152},39.76838,-86.15804,{"facility":154,"status":8,"city":155,"state":156,"zip":157,"country":80,"contacts":158,"geoPoint":163},"Southern Urology","Lafayette","Louisiana","70508",[159],{"name":160,"role":84,"phone":161,"email":162},"Simone Olivier","337-422-3770","solivier@ssmsla.com",{"lat":164,"lon":165},30.22409,-92.01984,{"facility":167,"status":8,"city":168,"state":156,"zip":169,"country":80,"contacts":170,"geoPoint":175},"Ochsner Clinic Foundation","New Orleans","70121",[171],{"name":172,"role":84,"phone":173,"email":174},"Rachel Graham","504-842-2961","rgraham@ochsner.org",{"lat":176,"lon":177},29.95465,-90.07507,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":80,"contacts":183,"geoPoint":188},"Washington University","St Louis","Missouri","63110",[184],{"name":185,"role":84,"phone":186,"email":187},"Megan Luther","314-747-2012","lutherm@wustl.edu",{"lat":189,"lon":190},38.62727,-90.19789,{"facility":192,"status":8,"city":193,"state":193,"zip":194,"country":80,"contacts":195,"geoPoint":200},"Weill Cornell","New York","10065",[196],{"name":197,"role":84,"phone":198,"email":199},"Alexis Watson","646-962-2347","alw4020@med.cornell.edu",{"lat":201,"lon":202},40.71427,-74.00597,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":80,"contacts":208,"geoPoint":210},"MidLantic Urology","Philadelphia","Pennsylvania","19004",[209],{"name":134,"role":84,"phone":135,"email":136},{"lat":211,"lon":212},39.95238,-75.16362,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":80,"contacts":218,"geoPoint":223},"Atlantic Urology Specialists","Myrtle Beach","South Carolina","29572",[219],{"name":220,"role":84,"phone":221,"email":222},"Crystal Mitchell","843-449-1010","crystal.mitchell@startresearch.com",{"lat":224,"lon":225},33.68906,-78.88669,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":80,"contacts":231,"geoPoint":236},"The Conrad Pearson Clinic","Germantown","Tennessee","38138",[232],{"name":233,"role":84,"phone":234,"email":235},"Russell Gribsby","901-236-0957","russell.grigsby@conradpearson.com",{"lat":237,"lon":238},35.08676,-89.81009,{"facility":240,"status":8,"city":241,"state":229,"zip":242,"country":80,"contacts":243,"geoPoint":248},"Urology Associates of Nashville","Nashville","37209",[244],{"name":245,"role":84,"phone":246,"email":247},"Rick Trotter","615-250-9268","CRTrotter@ua-pc.com",{"lat":249,"lon":250},36.16589,-86.78444,{"facility":252,"status":8,"city":253,"state":254,"zip":255,"country":80,"contacts":256,"geoPoint":261},"Urology Austin","Austin","Texas","78759",[257],{"name":258,"role":84,"phone":259,"email":260},"Christine Chau","512-410-3773","christine.chau@urologyaustin.com",{"lat":262,"lon":263},30.26715,-97.74306,{"facility":265,"status":8,"city":266,"state":267,"zip":268,"country":80,"contacts":269,"geoPoint":274},"Urology of Virginia","Virginia Beach","Virginia","23462",[270],{"name":271,"role":84,"phone":272,"email":273},"Julia Csenar","(757) 452-3463","jcsenar@urologyofva.net",{"lat":275,"lon":276},36.85293,-75.97799,{"facility":278,"status":8,"city":279,"state":280,"zip":281,"country":282,"contacts":283},"Australian Prostate Centre","Melbourne N.","Victoria","3055","Australia",[284,288,291,294],{"name":285,"role":84,"phone":286,"email":287},"Rachel Heerey","+61 (03) 8373 7600","info@apcr.org.au",{"name":289,"role":290},"Professor Anthony Costello, Urologist","PRINCIPAL_INVESTIGATOR",{"name":292,"role":293},"Mr Phillip Dundee, Urology Surgeon","SUB_INVESTIGATOR",{"name":295,"role":293},"Professor Rodney Hicks",{"facility":297,"status":8,"city":298,"country":282,"contacts":299,"geoPoint":306},"St Vincent's Hospital Sydney","Sydney",[300,304],{"name":301,"role":84,"phone":302,"email":303},"Shraddha Weir","+61 2 8382 1807","shraddha.weir@svha.org.au",{"name":305,"role":290},"Professor Louise Emmett",{"lat":307,"lon":308},-33.86785,151.20732,[],[],[],[],{"nct_id":4,"conditions":314,"biomarkers":316},[315],"Prostate Carcinoma",[317,318,319,320],"4Kscore","GPI wt Allele","KLK3 Gene","Prostate Cancer Antigen 3",{"nct_id":4,"found":66,"summary":322,"prompt_version":332},{"design":323,"status":324,"heading":325,"summary":326,"follow_up":327,"word_count":328,"commitments":329,"compensation":330,"drugs_mentioned":331},"This is an open-label, single-arm study, meaning you and your doctors will know what treatments you are receiving. It plans to enroll 338 participants across multiple locations.","completed","PSMA PET and MRI for Prostate Cancer Detection","This study is looking at how well a special type of scan, called PSMA PET, combined with an MRI (magnetic resonance imaging) can find prostate cancer. The PSMA PET scan uses a small amount of a drug called 68Ga-PSMA-11, which helps highlight prostate cancer cells. Researchers want to see if this combination is better than the usual ways doctors find prostate cancer. You might be able to join if you are a man at least 18 years old and your doctor suspects you might have prostate cancer, especially if you've had an MRI showing some concerns or have other risk factors like a high PSA (prostate-specific antigen) level. The study aims to enroll 338 participants. The main goals of the study will be measured after 12 months.","The primary goals of the study are measured at 12 months. If a biopsy is not performed, you will have a follow-up visit at 6 months.",127,"You would undergo MRI and PSMA PET scans, followed by a standard prostate biopsy. If your doctor decides not to perform a biopsy, you will have a follow-up visit at 6 months.","Not stated in the trial record.",[47],"v2"]