[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648437":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":110,"collaborators":112,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":30,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":30,"enrollmentInfo":125,"targetDuration":30,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":139,"whyStopped":30,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FTT-PET\u002FCT","EXPERIMENTAL","Participants will undergo two FluorThanatrace (FTT) Positron Emission Tomography\u002FComputed tomography (PET\u002FCT) scans; one at baseline prior to starting standard of care (SOC) PARP inhibitor (PARPi) therapy and one two weeks after initiation of PARPi therapy. Each cycle of PARPi therapy is 28 days.\n\nBlood samples for EnhanceAR-Seq ctDNA analysis will be collected from participants at baseline prior to therapy, post cycle 1,12 weeks after PARPi initiation, and at time of disease progression.\n\nEight participants will undergo an additional FTT-PET\u002FCT prior to initiation of PARPi therapy.",[13,14,15],"Drug: 1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one","Device: FTT-PET\u002FCT","Diagnostic Test: EnhanceAR-Seq",[17,26,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one","\\[18F\\]fluorthanatrace (FTT) is a positron emitting radiopharmaceutical that is administered as an intravenous (IV) solution via injection at a prescribed dose of 10mCi. A lesser dose may be injected if complete imaging data could be generated.",[9],[23,24,25],"FTT","[18F]FluorThanatrace","[18F]FTT",{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","A small intravenous (IV) catheter will be placed in the arm vein according to site's standard practice to allow injection of FTT. Approximately sixty minutes following administration of approximately 10 mCi of the radiotracer FTT, patients will undergo standard body PET\u002FCT imaging.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DIAGNOSTIC_TEST","EnhanceAR-Seq","Patients will undergo approximately 30 mL of peripheral blood sample collection to be used for analysis. For each sample, EnhanceAR-Seq will be performed on each of these samples, with somatic genomic alteration calling performed in plasma cell-free DNA with removal of background non-tumor variants using matched plasma-depleted whole blood germline samples.",[9],[37],{"name":38,"affiliation":5,"role":39},"Farrokh Dehdashti, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":30,"email":44},"CONTACT","314-362-1474","dehdashtif@wustl.edu",[46,75,91],{"facility":5,"status":30,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"St Louis","Missouri","63110","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.19789,38.62727,{"lat":56,"lon":55},[59,60,63,65,67,69,71,73],{"name":38,"role":42,"phone":43,"phoneExt":30,"email":44},{"name":61,"role":62,"phone":30,"phoneExt":30,"email":30},"Kooresh I Shoghi, PhD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":30,"phoneExt":30,"email":30},"Christopher A Maher, PhD",{"name":66,"role":62,"phone":30,"phoneExt":30,"email":30},"Richard Laforest, PhD",{"name":68,"role":62,"phone":30,"phoneExt":30,"email":30},"Cody Weimholt, MD",{"name":70,"role":62,"phone":30,"phoneExt":30,"email":30},"Melissa A Reimers, MD",{"name":72,"role":62,"phone":30,"phoneExt":30,"email":30},"Yu Tao, MD",{"name":74,"role":62,"phone":30,"phoneExt":30,"email":30},"Buck Rogers, PhD",{"facility":76,"status":30,"city":77,"state":78,"zip":79,"country":50,"countryCode":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Pennsylvania Abramson Cancer Center","Philadelphia","Pennsylvania","19104",{"type":53,"coordinates":81},[82,83],-75.16362,39.95238,{"lat":83,"lon":82},[86,90],{"name":87,"role":42,"phone":88,"phoneExt":30,"email":89},"Nei Taunk, MD","215-662-6515","taunk@upenn.edu",{"name":87,"role":39,"phone":30,"phoneExt":30,"email":30},{"facility":92,"status":30,"city":93,"state":94,"zip":95,"country":50,"countryCode":51,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":53,"coordinates":97},[98,99],-95.36327,29.76328,{"lat":99,"lon":98},[102,105,106,108],{"name":103,"role":42,"phone":104,"phoneExt":30,"email":30},"Lilie Lin, MD","713-792-2121",{"name":103,"role":39,"phone":30,"phoneExt":30,"email":30},{"name":107,"role":62,"phone":30,"phoneExt":30,"email":30},"Franklin Wong, MD",{"name":109,"role":62,"phone":30,"phoneExt":30,"email":30},"Patrick G Pilie, MD",{"type":111,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[113],{"name":114,"class":115},"National Cancer Institute (NCI)","NIH","100648437","phase-2-18ffluorthanatrace---positron-emission-tomography-ftt-pet-and-ctdna-to-predict-response-to-parp-inhibitor-therapy-in-metastatic-prostate-cancer-mpc-100648437",false,"NCT07723651","[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)","Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)","Inclusion Criteria:\n\n* Adult male patients 18 years of age or older\n* mCRPC with confirmed germline or somatic HRR (such as ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib\u002Fenzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm; gBRCA1m, gBRCA2m; ATMm, BRCA1m, BRCA2m for Olaparib +\u002F- abiraterone) mutations who are scheduled for SOC PARPi therapy.\n* Lesion size of at least 1.0 cm in longest dimension by imaging. If non-measurable, lesion needs to be clearly detected on other imaging studies such as bone scintigraphy, FDG-PET, PSMA-PET or MRI.\n* On continuous androgen deprivation therapy (ADT) with appropriately suppressed castrate testosterone levels of \\\u003C 50 ng\u002FdL, or prior bilateral orchiectomy.\n* Serum PSA of 2 ng\u002FmL or greater.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Receipt of prior PARP inhibitor therapy in any disease setting.\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer that is active at the time of enrollment.\n* Unable to tolerate approximately 30 min (total time) of PET\u002FCT imaging.","MALE","18 Years",{"count":126,"type":127},75,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","This multicenter center, open-label, baseline-controlled diagnostic imaging study designed to assess the use of Fluorthanatrace-Positron Emission tomography (FTT-PET) as a PARP inhibitor (PARPi) therapy predictive imaging biomarker and the use of EnhanceAR-Seq (ctDNA) in predicting response to therapy and to identify genomic alterations associated with resistance. Furthermore, to correlate changes in ctDNA and imaging (FTT-PET and standard of care imaging) to understand the dynamics of tumor response.",[133,134],"Metastatic Prostate Cancer","Prostate Cancer",[136,23,137,138],"PARP","PET","Prostate cancer","NOT_YET_RECRUITING","2026-07-19",{"date":142,"type":143},"2026-07-23","ACTUAL",{"date":145,"type":127},"2026-09-01",{"date":147,"type":127},"2032-03-31",{"name":5,"class":6},3]