[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07569926":3,"trial-entities:NCT07569926":149,"trial-summary:NCT07569926":153},{"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":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":138,"overall_officials":143,"references":147,"see_also_links":148},"NCT07569926","BED-FLC-401","Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence","The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence","NOT_YET_RECRUITING","2032-12-31","2026-05","2026-06-02","2026-06-01","Blue Earth Diagnostics","INDUSTRY",false,"The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence","This is a prospective, multi-institutional, Phase 4 study to assess change in management (CIM) following fluciclovine (18F) imaging in participants with prostate cancer who have a negative or equivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan at the time of any biochemical recurrence (BCR)",[19],"Prostate Cancer",[19,21,22,23],"Biochemical Recurrence (BCR)","Positron Emission Tomography (PET) Scan","Negative or equivocal PSMA PET scan","INTERVENTIONAL","DIAGNOSTIC",[27],"PHASE4",{"count":29,"type":30},142,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","fluciclovine (18F)","fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.",[37],"Patients Single intravenous administration of fluciclovine (18F) for PET Scan",[39],"Axumin",[41],{"measure":42,"timeFrame":43},"Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET\u002FCT scan.","fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days",[45,47,49,51,53,55,57],{"measure":46,"timeFrame":43},"For those participants with a change in management (CIM), percentage of participants with a recorded minor or major CIM following a fluciclovine (18F) PET\u002FCT scan.",{"measure":48,"timeFrame":43},"For those participants with a CIM, summary of the CIM groups following a fluciclovine (18F) PET\u002FCT scan.",{"measure":50,"timeFrame":43},"Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates.",{"measure":52,"timeFrame":43},"Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels.",{"measure":54,"timeFrame":43},"Percentage of participants with any recorded CIM following a positive\u002Fnegative fluciclovine (18F) PET\u002FCT",{"measure":56,"timeFrame":43},"Percentage of participants with a recorded minor or major CIM following a positive\u002Fnegative fluciclovine (18F) PET\u002FCT",{"measure":58,"timeFrame":43},"For those participants with a CIM, summary of CIM groups following a positive\u002Fnegative fluciclovine (18F) PET\u002FCT","MALE","18 Years",null,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Participants must be males aged ≥18 years at Screening.\n2. Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 \\[fluciclovine (18F) PET\u002FCT scan\\]), regardless of findings on conventional imaging.\n3. Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng\u002FmL (completed \\>6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng\u002FmL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations.\n4. Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection.\n5. Participants must provide written informed consent before any study-specific procedures or interventions are performed.\n6. Ability of the participants to comply with planned study procedures\n\nExclusion Criteria:\n\n1. Participants with known metastatic castrate resistant prostate cancer.\n2. Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements.\n3. Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET\u002FCT scan.\n4. Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET\u002FCT scan.\n5. Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F).\n6. Participants who have received salvage therapy for the current episode of BCR.\n7. Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET\u002FCT scans.",[67,68],"ADULT","OLDER_ADULT",[70,83,94,105,116,127],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":80},"University of California San Diego Health","San Diego","California","92103","United States",[77],{"name":78,"role":79},"Sherief H Gamie, MD","CONTACT",{"lat":81,"lon":82},32.71571,-117.16472,{"facility":84,"city":85,"state":86,"zip":87,"country":75,"contacts":88,"geoPoint":91},"Emory University","Atlanta","Georgia","30322",[89],{"name":90,"role":79},"Ismaheel Lawal, MD",{"lat":92,"lon":93},33.749,-84.38798,{"facility":95,"city":96,"state":97,"zip":98,"country":75,"contacts":99,"geoPoint":102},"Massachusetts General Hospital","Boston","Massachusetts","02114",[100],{"name":101,"role":79},"Pedram Heidari, MD",{"lat":103,"lon":104},42.35843,-71.05977,{"facility":106,"city":107,"state":108,"zip":109,"country":75,"contacts":110,"geoPoint":113},"Washington University","St Louis","Missouri","63110",[111],{"name":112,"role":79},"Ashwin Parihar, MD",{"lat":114,"lon":115},38.62727,-90.19789,{"facility":117,"city":118,"state":119,"zip":120,"country":75,"contacts":121,"geoPoint":124},"Oregon Health & Science University","Portland","Oregon","97239",[122],{"name":123,"role":79},"Nadine Mallak, MD",{"lat":125,"lon":126},45.52345,-122.67621,{"facility":128,"city":129,"state":130,"zip":131,"country":75,"contacts":132,"geoPoint":135},"Urology Austin","Austin","Texas","78759",[133],{"name":134,"role":79},"Brian Mazzarella, MD",{"lat":136,"lon":137},30.26715,-97.74306,[139],{"name":140,"role":79,"phone":141,"email":142},"BED-Flc-401 Study Team","+44 (0) 1865 507300","bed-flc-401_study@bracco.com",[144],{"name":123,"affiliation":145,"role":146},"Oregon Health and Science University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":150,"biomarkers":152},[151],"Prostate Carcinoma",[],{"nct_id":4,"found":154,"summary":155,"prompt_version":165},true,{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is a prospective, multi-institutional study that plans to enroll 142 participants. It is not specified if it is randomized or blinded.","completed","Fluciclovine (18F) PET for Prostate Cancer After Previous PSMA PET Scans","This study is looking at how a special type of scan, called fluciclovine (18F) PET, can help doctors manage prostate cancer. This is for men who have had their prostate cancer come back (biochemical recurrence) after treatment, and whose previous PSMA (Prostate-Specific Membrane Antigen) PET scans didn't clearly show where the cancer was. The study wants to see if the fluciclovine (18F) PET scan changes the treatment plan for these patients. To join, you must be a male aged 18 or older with prostate cancer recurrence and a recent negative or unclear PSMA PET scan. The main goal is to measure how many participants have a change in their treatment plan after getting the fluciclovine (18F) PET\u002FCT scan, which will be measured within 30 days of the scan. The current status of this study is unclear, and it plans to enroll 142 participants.","The primary outcome, change in management, is measured within 30 calendar days after the fluciclovine (18F) scan.",143,"Participants will receive an intravenous injection of fluciclovine (18F) and undergo a PET\u002FCT scan. This scan will occur at least 24 hours after a piflufolastat (18F) scan, but within 30 days.","Not stated in the trial record.",[34],"v2"]