[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100323782":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":40,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":40,"enrollmentInfo":75,"targetDuration":40,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":44,"whyStopped":40,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radioactive Diagnostic Imaging","EXPERIMENTAL","Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.",[13,14],"Drug: F-DCFPyL Injection","Diagnostic Test: PSMA PET",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","F-DCFPyL Injection","F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.",[9],[22],"Imaging agent",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","PSMA PET","PSMA PET imaging (for men with high GC \\>0.45) will be done after 2 years post-treatment, then yearly up to 5 years.",[9],[29,30],"Prostate-specific Membrane Antigen (PSMA)","Positron Emission Tomography (PET)",[32],{"name":33,"affiliation":5,"role":34},"Kosj Yamoah, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Riley Smith","CONTACT","813-799-6821",null,"Riley.Smith@moffitt.org",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-82.45843,27.94752,{"lat":54,"lon":53},[57,58],{"name":33,"role":34,"phone":40,"phoneExt":40,"email":40},{"name":59,"role":34,"phone":40,"phoneExt":40,"email":40},"Kenneth Gage, M.D., Ph.D.",{"type":61,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[63],{"name":64,"class":65},"Progenics Pharmaceuticals, Inc.","INDUSTRY","100323782","phase-2-psma-pet-imaging-for-detecting-early-metastatic-prostate-cancer-in-men-w-high-decipher-test-scores-100323782",false,"NCT03495427","PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w\u002F High Decipher Test Scores","The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)","Inclusion Criteria:\n\n* This study will enroll 60 patients previously enrolled to MCC#18523, \"A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)\" that had high risk Decipher test results (Decipher score \\>0.45).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Previously enrolled to MCC#18523\n* Genomic Classifier (GC) testing successfully completed on biopsy and\u002For surgical specimen\n* Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\\>0.45)\n* Treated with radical prostatectomy (RP) or radiation therapy (RT) (+\u002F- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up\n* Age \\> 18\n\nExclusion Criteria:\n\n* No follow up information available post treatment\n* Unable to undergo PET imaging due to pre-existing comorbidities and\u002For claustrophobia\n* Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection","MALE","18 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE2","PHASE3","This study will enroll 60 patients previously enrolled to MCC#18523, \"A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)\" that had high risk Decipher test results (Decipher score \\>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.",[84,85],"Prostate Cancer","Recurrent Prostate Cancer",[87],"radioactive diagnostic imaging","2026-02-26",{"date":90,"type":91},"2026-03-02","ACTUAL",{"date":93,"type":91},"2019-12-18",{"date":95,"type":77},"2029-05",{"name":5,"class":6},1]