[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614858":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":21,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":21,"enrollmentInfo":79,"targetDuration":21,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":45,"whyStopped":21,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"rhPSMA-7.3 (18F) PET\u002FCT Imaging","EXPERIMENTAL","Participants in this arm will undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT (flotufolastat F18, POSLUMA®) imaging and standard multiparametric MRI prior to confirmatory prostate biopsy. All participants receive the same imaging procedures; there are no control or comparison arms.",[13,14],"Radiation: rhPSMA-7.3 (18F) PET\u002FCT Imaging (Flotufolastat F18, POSLUMA®)","Drug: Flotufolastat F18",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","rhPSMA-7.3 (18F) PET\u002FCT Imaging (Flotufolastat F18, POSLUMA®)","Participants will undergo a single rhPSMA-7.3 (¹⁸F) PET\u002FCT scan using flotufolastat F18 (POSLUMA®), an FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET\u002FCT image acquisition. The scan will be performed according to institutional imaging protocols, approximately 50-70 minutes post-injection.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Flotufolastat F18","An FDA-approved PSMA-targeted radiotracer. The radiotracer will be administered intravenously at the standard diagnostic dose prior to PET\u002FCT image acquisition.",[9],[28],"POSLUMA®",[30],{"name":31,"affiliation":5,"role":32},"Ashutosh Tewari","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},"Neeraja Tillu, MBBS, MS, MCh.","CONTACT","646-799-1870","neeraja.tillu@mountsinai.org",{"name":40,"role":36,"phone":21,"phoneExt":21,"email":41},"Monali Fatterpekar, PhD","monali.fatterpekar@mountsinai.org",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Mount Sinai Hospital \u002F Icahn School of Medicine at Mount Sinai","RECRUITING","New York","10029","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-74.00597,40.71427,{"lat":54,"lon":53},[57,59,62],{"name":58,"role":36,"phone":37,"phoneExt":21,"email":38},"Neeraja Tillu, MBBS, MS, MCh",{"name":60,"role":36,"phone":21,"phoneExt":21,"email":61},"Monali Fatterpekar","Monali.Fatterpekar@mountsinai.org",{"name":31,"role":32,"phone":21,"phoneExt":21,"email":21},{"type":32,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Ashutosh Kumar Tewari","Professor and System Chair",[67],{"name":68,"class":69},"Blue Earth Diagnostics","INDUSTRY","100614858","phase-2-diagnostic-utility-of-rhpsma-73-18f-petct-in-men-with-prostate-cancer-on-active-surveillance-100614858",false,"NCT07285057","Diagnostic Utility of rhPSMA-7.3 (18F) PET\u002FCT in Men With Prostate Cancer on Active Surveillance","Diagnostic Utility of rhPSMA-7.3 (18F) PET \u002FCT Imaging in Patients With Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* Male participants aged ≥18 years.\n* Histologically confirmed diagnosis of prostate adenocarcinoma.\n* Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \\\u003C10 ng\u002FmL, cT1-T2a Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng\u002FmL, cT2b-c Currently managed with active surveillance.\n* Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT imaging, mpMRI, and confirmatory prostate biopsy.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer.\n* Contraindication to 3-T mpMRI.\n* Significant intercurrent morbidity\\*\\* limiting compliance with study protocols.\n\n  \\*\\* Significant intercurrent morbidity refers to a substantial medical condition or complication that arises during a study or treatment, which is severe enough to impact the patient's participation, treatment outcomes, or overall prognosis. These conditions may be unrelated to the primary disease but can influence clinical decision-making, treatment efficacy, and patient safety. Examples include major infections, cardiovascular events, organ failure, or significant worsening of pre-existing comorbidities (https:\u002F\u002Fdoi.org\u002F10.1016\u002FS1053-4296(03)00031-6).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.","MALE","18 Years",{"count":80,"type":81},120,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET\u002FCT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET\u002FCT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET\u002FCT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET\u002FCT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET\u002FCT, MRI, and pathology, and evaluate the predictive value of PET\u002FCT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.",[87,88,89],"Prostatic Neoplasms","Prostate Cancer","Prostate Adenocarcinoma",[91,92,93,94,95,96],"Prostate cancer","Prostatic neoplasms","Active surveillance","PSMA PET\u002FCT","rhPSMA-7.3","Prostate biopsy","2026-02-20",{"date":99,"type":100},"2026-02-23","ACTUAL",{"date":102,"type":100},"2026-02-10",{"date":104,"type":81},"2027-05-01",{"name":5,"class":6},1]