[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582122":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":21,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Technical University of Munich","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Prostate cancer patients with biochemical recurrence after negative\u002Finconclusive PSMA PET\u002FCT",null,"This cohort comprises male patients with biochemically recurrent prostate cancer following definitive treatment-such as surgery or radiotherapy-who have previously undergone a PSMA PET\u002FCT scan that was either negative or inconclusive. The primary intervention of interest is the fluciclovine (18F) PET\u002FCT scan, which is performed as part of their routine clinical care to detect sites of recurrent disease.",[13],{"name":14,"affiliation":5,"role":15},"Matthias Eiber, MD","PRINCIPAL_INVESTIGATOR",[17],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+49 89 4140 0","matthias.eiber@tum.de",[22,41],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"University Hospital Augsburg","NOT_YET_RECRUITING","Augsburg","Bavaria","86156","Germany","DE",{"type":31,"coordinates":32},"Point",[33,34],10.89851,48.37154,{"lat":34,"lon":33},[37],{"name":38,"role":18,"phone":39,"phoneExt":10,"email":40},"Constantin Lapa, MD","+49 821 4003040","info@uk-augsburg.de",{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":28,"countryCode":29,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"TUM University Hospital","RECRUITING","Munich","81675",{"type":31,"coordinates":47},[48,49],11.57549,48.13743,{"lat":49,"lon":48},[52],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":53},"sekretariat@mri.tum.de",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100582122","a-prospective-bicentric-evaluation-of-fluciclovine-pet-imaging-in-patients-with-prior-negative-or-inconclusive-psma-ligand-pet-100582122",false,"NCT06859203","A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET","Prospective Evaluation of Fluciclovine (18F) PET\u002FCT in Patients with Prior Negative PSMA PET\u002FCT","REFINE","Inclusion Criteria:\n\n* Patient is male and aged \\>18 years old.\n* Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of hormone sensitive PCa, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant therapy, c) RT and\u002For androgen deprivation therapy \\[ADT\\].\n* An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: 1) Following RP with or without adjuvant therapy: PSA ≥0.2 ng\u002FmL followed by a subsequent confirmatory PSA value ≥0.2 ng\u002FmL and within the total range of 0.2 and 2 ng\u002Fml. PSA must be measured at least 6 weeks after RP. 2) Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng\u002FmL and within the total range of 2 and 4 ng\u002Fml\n\nExclusion Criteria:\n\n* Patients with any medical condition or circumstance (including receiving an investigational product) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Current or recent androgen deprivation therapy (ADT) within 3 months prior to the start of the study, which includes surgical orchidectomy, continuous or intermittent LHRH agonist\u002Fantagonist, and first-\u002Fsecond-generation anti androgen alone or combined with LHRH agonist\u002Fantagonist.","MALE","18 Years",{"count":67,"type":68},94,"ESTIMATED","OBSERVATIONAL","The REFINE study is evaluating whether a fluciclovine (18F) PET\u002FCT scan can detect recurrent prostate cancer in patients whose previous PSMA PET\u002FCT was negative or inconclusive.",[72],"Biochemical Recurrence of Malignant Neoplasm of Prostate",[74,75,76,77,78,79,80],"prostate cancer","biochemical recurrence","PET","PSMA","fluciclovine","BCR","prostate","2025-02-27",{"date":83,"type":84},"2025-03-05","ACTUAL",{"date":86,"type":68},"2025-03",{"date":88,"type":68},"2027-12",{"name":5,"class":6},2]