[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Curium US LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100534155","phase-3-copper-cu-64-psma-it-pet-imaging-in-men-with-newly-diagnosed-prostate-cancer-100534155",false,"NCT06235151","Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer","Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET\u002FCT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection","Solar-Stage","Inclusion Criteria:\n\n* Patients with histologically proven prostate adenocarcinoma.\n* Planned prostatectomy with pelvic lymph node dissection.\n* Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.\n* Male aged greater than or equal to 18 years.\n* Able to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.\n* Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.\n* Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.\n* Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\\&T administration.\n* Patients with known hypersensitivity to the active substance or any of the excipients of the IP.\n* Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.","MALE","18 Years",{"count":20,"type":21},439,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\\&T injection for PET\u002FCT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.",[27,28],"Prostate Cancer","Prostate Adenocarcinoma",[30,27,31,15,32,33,34],"PSMA","Initial Staging","Cu-64 PSMA","PET","Solar","RECRUITING","2026-06-02",{"date":38,"type":39},"2026-06-04","ACTUAL",{"date":41,"type":39},"2024-04-01",{"date":43,"type":21},"2026-09",{"name":45,"class":46},"Curium US LLC","INDUSTRY",44,""]