[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06706921":3,"trial-entities:NCT06706921":103,"trial-summary:NCT06706921":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":30,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":50,"secondary_outcomes":54,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":72,"locations":75,"central_contacts":96,"overall_officials":100,"references":101,"see_also_links":102},"NCT06706921","1819674","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","RECRUITING","2027-11-01","2024-09","2024-11-27","2024-12-15","VA Greater Los Angeles Healthcare System","FED",false,"This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.","The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET\u002FCT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed.\n\nAll patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.",[19,20,21,22,23,24,25,26,27,28,29],"Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","Metastatic Prostate Cancer","Male Urogenital Diseases","Prostatic Diseases","Urogenital Diseases, Male","Genital Diseases, Male","Neoplasms","Neoplasms by Site","Urogenital Neoplasms","Genital Neoplasms, Male",[31,32,33,34,35],"Prostate cancer","PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","INTERVENTIONAL","DIAGNOSTIC",[39],"PHASE4",{"count":41,"type":42},15,"ESTIMATED",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48},"DRUG","18F-Fluciclovine PET\u002FCT Scan","In this prospective study, an 18F-Fluciclovine PET\u002FCT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET\u002FCT will be acquired within 7 days from the PSMA PET.",[49],"18F-Fluciclovine PET\u002FCT",[51],{"measure":6,"description":52,"timeFrame":53},"Whole-body and lesion-level SUVmean, SUVmax. SUVmax, or maximum standardized uptake value, is a measurement used in positron emission tomography (PET) scans to quantify how much glucose a tumor is metabolizing.","From enrollment to end of treatment at 34 weeks.",[55],{"measure":56,"description":57,"timeFrame":58},"Usefulness of Tumor Heterogeneity Assessment in Patients in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome.","Tumor volume on FDG, Axumin and DCFPyL PET\u002FCT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc).","From enrollment to end of treatment at 34 weeks","MALE","18 Years",null,{"inclusion":63,"exclusion":67,"raw_text":71},[64,65,66],"Patients with mCRPC scheduled to undergo LuPSMA RLT.","Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.","Ability of providing written informed consent.",[68,69,70],"Less than 18 years-old at the time of radiopharmaceutical administration.","Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.","Contraindications to LuPSMA RLT.","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":13,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":93},"Los Angeles","California","90073","United States",[82,87,91],{"name":83,"role":84,"phone":85,"email":86},"Gholam Berenji, MD","CONTACT","310-268-3547","gholam.berenji@va.gov",{"name":88,"role":84,"phone":89,"email":90},"Janake Wijesuriya, BS","310-977-5209","Janake.Wijesuriya@va.gov",{"name":83,"role":92},"PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},34.05223,-118.24368,[97,99],{"name":83,"role":84,"phone":85,"email":98},"Gholam.Berenji@va.gov",{"name":88,"role":84,"phone":89,"email":90},[],[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Prostate Carcinoma",[],{"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 a single-center, exploratory study without a specified phase, involving about 15 participants.","completed","18F-Fluciclovine PET\u002FCT for Predicting Outcomes in Prostate Cancer Patients Receiving 177Lu-PSMA-617 Therapy","This study is looking at how a special type of scan, called an 18F-Fluciclovine PET\u002FCT, can help predict how well men with metastatic castration-resistant prostate cancer (mCRPC) will respond to a treatment called 177Lu-PSMA-617 (LuPSMA RLT). Researchers will take these scans at the beginning of treatment and after the 2nd, 4th, and 6th cycles of LuPSMA RLT. They will compare the scan results with your clinical outcome to see if the scans can predict how effective the treatment will be for you. You can join if you are an adult man with mCRPC who is scheduled to receive LuPSMA RLT and are willing to have several scans. The study aims to understand if these scans can help doctors better predict treatment success. The current status of this study is unclear, and it plans to enroll 15 participants.","Your clinical outcome will be followed from enrollment until the end of treatment, which is approximately 34 weeks.",137,"You would undergo multiple 18F-Fluciclovine PET\u002FCT scans at baseline and after the 2nd, 4th, and 6th cycles of LuPSMA RLT. These scans will be done within 7 days of your PSMA PET scans.","Not stated in the trial record.",[],"v2"]