[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484444":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":10,"id":55,"slug":10,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"Participants with biochemically recurrent prostate cancer",[13],"Drug: 18F-DCFpyL",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","18F-DCFpyL","Administered to Cohort.",[9],[21],{"name":22,"affiliation":23,"role":24},"Melissa L Abel, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Amy R Hankin, P.A.-C","CONTACT","(240) 858-3149","amy.hankin@nih.gov",{"name":22,"role":28,"phone":32,"phoneExt":10,"email":33},"(240) 447-5353","melissa.abel@nih.gov",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.10026,38.98067,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":52,"phoneExt":10,"email":10},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100484444",false,"NCT05588128","Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL","A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL","* INCLUSION CRITERIA:\n* History of primary treatment for prostate cancer (either surgery or radiation)\n* Serum PSA \\>= 0.50\n* Serum testosterone \\>100\n* Age \\>=18 years\n* Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable\n* The ability of a participant to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \\[MRI\\] as clinically indicated).\n\nNOTE: Lymph nodes \\\u003C= 1.5 cm in the shortest dimension are allowed.\n\n* Evidence of bone lesions on Tc99 bone scan\n* Prostatectomy within 1 year before the study intervention\n* Androgen deprivation therapy (ADT) within the 6 months before the study intervention\n* Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.","MALE","18 Years",{"count":64,"type":65},350,"ESTIMATED","OBSERVATIONAL","Background:\n\nProstate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer.\n\nObjective:\n\nTo learn more about how 18F-DCFPyL PET\u002FCT scans detect change over time in men with recurrent prostate cancer.\n\nEligibility:\n\nMen aged 18 and older with prostate cancer that returned after treatment.\n\nDesign:\n\nParticipants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis.\n\nParticipants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET\u002FCT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET\u002FCT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes.\n\nParticipants will return for blood tests every 3 months.\n\nParticipants will return for additional scans with 18F-DCFPyL on this schedule:\n\nOnce a year if their previous scan was negative for prostate cancer.\n\nEvery 6 months if their previous scan was positive for prostate cancer.\n\nParticipants may be in the study up to 5 years.",[69,70],"Prostate Cancer","Biochemically Recurrent",[72,73,74],"Cancer Of Prostate","Natural History","Imaging","2026-06-27",{"date":77,"type":78},"2026-06-30","ACTUAL",{"date":80,"type":78},"2023-03-21",{"date":82,"type":65},"2027-12-31",{"name":23,"class":6},1]