[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609910":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":51,"collaborators":23,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":23,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":23,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":33,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"POSLUMA PET scan","EXPERIMENTAL","Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.",[13],"Drug: Flotufolastat F 18",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Flotufolastat F 18","A PSMA-targeted PET imaging agent used to detect and locate prostate cancer during PET scans that will be administered one time to each study subject.",[9],[21,22],"(18)F-rhPSMA-7.3","POSLUMA",null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Shelby Sparks","CONTACT","904-244-7340","Urologyresearch@jax.ufl.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"UF Health - Jacksonville","RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-81.65565,30.33218,{"lat":43,"lon":42},[46,48],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":47},"shelby.sparks@ufhealth.org",{"name":49,"role":50,"phone":23,"phoneExt":23,"email":23},"Kethandapatti Balaji, MD","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100609910","phase-2-posluma-18f-rhpsma-73-pet-ct-for-pirads-23-lesions-100609910",false,"NCT07220720","POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2\u002F3 Lesions","Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI","Inclusion Criteria:\n\n1. The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.\n2. The patient is male and at least 18 years of age.\n3. The patient has not previously undergone a prostate biopsy.\n4. The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).\n5. The patient is a candidate for a targeted MRI\u002FUS biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates.\n6. The patient has PIRADS 2 and\u002For PIRADS 3 lesions detected by a board-certified radiologist.\n\nExclusion Criteria:\n\n1. Patients with a prior diagnosis of prostate cancer.\n2. Patients with any medical condition or circumstance that, in the investigator's opinion, could compromise the study data or prevent the patient from fulfilling the study requirements.\n3. Patients participating in another interventional clinical trial within the past 30 days.\n4. Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.","MALE","18 Years","100 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.",[71],"Prostate",[73,74,75,76,77],"prostate cancer","posluma","pirads 2","pirads 3","prostate biopsy","2026-04-09",{"date":80,"type":81},"2026-04-13","ACTUAL",{"date":83,"type":81},"2025-11-04",{"date":85,"type":65},"2032-11-15",{"name":5,"class":6},1]