[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582403":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Very Low Prostate Specific Antigen Recurrence",null,"Men \\>18 years of age will undergo screening to confirm eligibility for this research study. Participants will receive a PET scan with flotufolastat F 18 injection on study visit 2.",[13],"Diagnostic Test: Positron Emission Tomography (PET)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Positron Emission Tomography (PET)","This is a PET scan with flotufolastat F 18 injection.",[9],[21],"Flotufolastat F 18 PET",[23],{"name":24,"affiliation":5,"role":25},"Jason Efstathiou, MD, DPhil","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","617-726-5866","jefstathiou@mgb.org",[32,47],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-71.05977,42.35843,{"lat":43,"lon":42},[46],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},{"facility":48,"status":33,"city":34,"state":35,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Dana Farber Cancer Institute","02215",{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},[54],{"name":55,"role":28,"phone":56,"phoneExt":10,"email":57},"Jonathan Leeman, MD","617-732-6452","JELEEMAN@BWH.HARVARD.EDU",{"type":25,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jason Efstathiou","Principal Investigator",[62],{"name":63,"class":64},"Blue Earth Diagnostics","INDUSTRY","100582403","flotufolastat-f-18-pet-in-men-with-very-low-psa-recurrence-100582403",false,"NCT06862856","Flotufolastat F 18 PET in Men With Very Low PSA Recurrence","A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence","Inclusion Criteria:\n\n* Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.\n* Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng\u002FmL, and obtained within 60 days of PET\u002FCT.\n* At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.\n* Participants with a clinical flotufolastat F 18 PSMA PET\u002FCT scan prescribed as part of the standard of care management.\n* Age ≥18 years.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone \\[LHRH\\] agonist alone \\[continuous or intermittent\\]; LHRH antagonist alone \\[continuous or intermittent\\]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist\u002Fantagonist).\n* Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.\n* Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \\\u003C24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET\u002FCT. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.","MALE","18 Years",{"count":75,"type":76},50,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.",[80,81],"Prostate Cancer (Adenocarcinoma)","Prostate Specific Antigen",[83,84,85],"flotufolastat F 18 positron emission tomography","low prostate specific antigen recurrence","prostate cancer","2026-05-13",{"date":88,"type":89},"2026-05-15","ACTUAL",{"date":91,"type":89},"2025-05-20",{"date":93,"type":76},"2026-12-01",{"name":5,"class":6},2]