[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03495427":3,"trial-entities:NCT03495427":102,"trial-summary:NCT03495427":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":48,"secondary_outcomes":53,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":74,"locations":77,"central_contacts":92,"overall_officials":98,"references":100,"see_also_links":101},"NCT03495427","MCC-19291","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)","RECRUITING","2029-05","2026-02","2026-03-02","2019-12-18","H. Lee Moffitt Cancer Center and Research Institute","OTHER",false,"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.","Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent\u002Fmetastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent\u002Fmetastatic prostate cancer may lead to better management of prostate cancer patients in the future.",[19,20],"Prostate Cancer","Recurrent Prostate Cancer",[22],"radioactive diagnostic imaging","INTERVENTIONAL","DIAGNOSTIC",[26,27],"PHASE2","PHASE3",{"count":29,"type":30},60,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","F-DCFPyL Injection","F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.",[37],"Radioactive Diagnostic Imaging",[39],"Imaging agent",{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"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.",[37],[46,47],"Prostate-specific Membrane Antigen (PSMA)","Positron Emission Tomography (PET)",[49],{"measure":50,"description":51,"timeFrame":52},"Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings","To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.","Up to 5 years",[54],{"measure":55,"description":56,"timeFrame":52},"Rate of Positive PSMA-PET Findings","5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.","MALE","18 Years",null,{"inclusion":61,"exclusion":69,"raw_text":73},[62,63,64,65,66,67,68],"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).","Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1","Previously enrolled to MCC#18523","Genomic Classifier (GC) testing successfully completed on biopsy and\u002For surgical specimen","Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\\>0.45)","Treated with radical prostatectomy (RP) or radiation therapy (RT) (+\u002F- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up","Age \\> 18",[70,71,72],"No follow up information available post treatment","Unable to undergo PET imaging due to pre-existing comorbidities and\u002For claustrophobia","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","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",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Tampa","Florida","33612","United States",[84,87],{"name":85,"role":86},"Kosj Yamoah, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":88,"role":86},"Kenneth Gage, M.D., Ph.D.",{"lat":90,"lon":91},27.94752,-82.45843,[93],{"name":94,"role":95,"phone":96,"email":97},"Riley Smith","CONTACT","813-799-6821","Riley.Smith@moffitt.org",[99],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Prostate Carcinoma",[106],"Decipher",{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study planning to enroll 60 male participants. It is not specified if it is randomized or blinded.","completed","PSMA-PET Imaging for Early Metastatic Prostate Cancer in Men with High Decipher Scores","This study is looking at a new imaging test called F-DCFPyL-PSMA PET to see how well it finds prostate cancer that has come back or spread (recurrent\u002Fmetastatic prostate cancer). The F-DCFPyL Injection is a special radioactive dye used with the PSMA PET scan. Researchers want to see if this new scan can accurately detect early signs of cancer spread in men who had high-risk Decipher test scores when they were first diagnosed. The study will enroll 60 men who previously participated in another study (VANDAAM) and had high Decipher scores (above 0.45). The main goal is to see how well the high Decipher score matches up with positive findings on the PSMA-PET imaging over a period of up to 5 years.","Participants will be followed for up to 5 years to measure the concordance between their Decipher score and PSMA-PET findings.",121,"You would undergo PSMA PET imaging at 2 years after your initial treatment, and then yearly for up to 5 years.","Not stated in the trial record.",[34,42],"v2"]