[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532703":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":130,"centralContacts":135,"locations":141,"responsibleParty":159,"collaborators":161,"id":165,"slug":113,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":113,"eligibilityCriteria":170,"healthyVolunteers":166,"sex":171,"minAge":172,"maxAge":113,"enrollmentInfo":173,"targetDuration":113,"studyType":176,"phases":177,"briefSummary":179,"conditions":180,"keywords":113,"overallStatus":143,"whyStopped":113,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Jonsson Comprehensive Cancer Center","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (177Lu-PSMA-617)","EXPERIMENTAL","Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Beginning with the third cycle, treatments may be postponed beyond the 6 weeks interval based on defined response criteria (\"treatment holiday\" period). Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET\u002FCT throughout the trial. Patients also undergo SPECT\u002FCT, PET\u002FCT, or CT on the trial.",[13,14,15,16,17,18,19],"Procedure: Computed Tomography","Other: Gallium Ga 68 Gozetotide","Drug: Lutetium Lu 177 Vipivotide Tetraxetan","Procedure: Positron Emission Tomography","Procedure: PSMA PET Scan","Other: Questionnaire Administration","Procedure: Single Photon Emission Computed Tomography",{"label":21,"type":22,"description":23,"interventionNames":24},"Arm II (177Lu-PSMA-617)","ACTIVE_COMPARATOR","Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET\u002FCT throughout the trial. Patients also undergo SPECT\u002FCT, PET\u002FCT, or CT on the trial.",[13,14,15,16,17,18,19],[26,41,73,88,101,109,114],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Computed Tomography","Undergo PSMA PET\u002FCT, SPECT\u002FCT, PET\u002FCT and CT",[9,21],[32,33,34,35,36,37,38,39,40],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography",{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Gallium Ga 68 Gozetotide","Given IV",[9,21],[46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC","(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68Ga)Glu-urea-Lys(Ahx)-HBED-CC","68Ga-DKFZ-PSMA-11","68Ga-HBED-CC-PSMA","68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","68Ga-PSMA","68Ga-PSMA-11","68Ga-PSMA-HBED-CC","[68Ga] Prostate-specific Membrane Antigen 11","[68Ga]GaPSMA-11","AAA 517","AAA-517","AAA517","Ga PSMA","Ga-68 labeled DKFZ-PSMA-11","Ga-68 labeled PSMA-11","GA-68 PSMA-11","Gallium Ga 68 PSMA-11","Gallium Ga 68-labeled PSMA-11","GALLIUM GA-68 GOZETOTIDE","Gallium-68 PSMA","Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","GaPSMA","PSMA-HBED-CC GA-68",{"type":74,"name":75,"description":43,"armGroupLabels":76,"otherNames":77},"DRUG","Lutetium Lu 177 Vipivotide Tetraxetan",[9,21],[78,79,80,81,82,83,84,85,86,87],"177Lu-labeled PSMA-617","177Lu-PSMA-617","AAA 617","AAA-617","AAA617","Lu177-PSMA-617","Lutetium Lu 177-PSMA-617","LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN","Lutetium-177-PSMA-617","Pluvicto",{"type":27,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Positron Emission Tomography","Undergo PET\u002FCT",[9,21],[93,94,95,96,97,98,99,100],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":27,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"PSMA PET Scan","Undergo PSMA PET\u002FCT",[9,21],[106,107,108],"Prostate-specific Membrane Antigen PET","PSMA PET","PSMA-Positron emission tomography",{"type":6,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Questionnaire Administration","Ancillary studies",[9,21],null,{"type":27,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"Single Photon Emission Computed Tomography","Undergo SPECT\u002FCT",[9,21],[119,120,121,122,123,124,125,126,127,128,129],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","Single-Photon Emission Computed","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","ST","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",[131],{"name":132,"affiliation":133,"role":134},"Jeremie Calais","UCLA \u002F Jonsson Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[136],{"name":137,"role":138,"phone":139,"phoneExt":113,"email":140},"Stephanie Lira","CONTACT","310-206-0596","StephanieLira@mednet.ucla.edu",[142],{"facility":133,"status":143,"city":144,"state":145,"zip":146,"country":147,"cosmosGeoPoint":148,"geoPoint":153,"contacts":154},"RECRUITING","Los Angeles","California","90095","United States",{"type":149,"coordinates":150},"Point",[151,152],-118.24368,34.05223,{"lat":152,"lon":151},[155,158],{"name":132,"role":138,"phone":156,"phoneExt":113,"email":157},"213-769-9636","jcalais@mednet.ucla.edu",{"name":132,"role":134,"phone":113,"phoneExt":113,"email":113},{"type":160,"investigatorFullName":113,"investigatorTitle":113,"investigatorAffiliation":113,"oldNameTitle":113,"oldOrganization":113},"SPONSOR",[162],{"name":163,"class":164},"Novartis Pharmaceuticals","INDUSTRY","100532703",false,"NCT06216249","Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)","A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks (FLEX-MRT)","Inclusion Criteria:\n\n* Patients must have prostate cancer proven by histopathology\n* Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging \\[MRI\\], bone scan, PET)\n* Patients must have received at least one regimen of chemotherapy for mCRPC\n* Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)\n* Patients must be eligible by PSMA PET VISION criteria. PSMA PET\u002FCT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617\n* White blood cell (WBC) ≥ 2,500\u002Ful\n* Platelets (PLT) ≥ 100,000\u002Ful\n* Hemoglobin (Hb) ≥ 9.0 g\u002Fdl\n* Absolute neutrophil count (ANC) ≥ 1,500 ul\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patients must be adults ≥ 18 years of age\n* Patients must have the ability to understand and sign an approved informed consent form (ICF)\n* Patients must have the ability to understand and comply with all protocol requirements\n\nExclusion Criteria:\n\n* Prior cycle of 177Lu-PSMA-617 therapy\n* Less than 6 weeks between last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation) and first cycle of 177Lu-PSMA-617 therapy\n* Glomerular filtration rate (GFR) \\\u003C 50 ml\u002Fmin\n* Urinary tract obstruction or marked hydronephrosis","MALE","18 Years",{"count":174,"type":175},90,"ESTIMATED","INTERVENTIONAL",[178],"PHASE2","In advanced metastatic castration resistant prostate cancer (mCRPC) progressing after chemotherapy and androgen receptor (AR)-targeted therapy 177Lu-PSMA-617 is an effective treatment. 177Lu-PSMA-617 RLT is administered with a fixed schedule: 6 treatment cycles, administered every 6 weeks. However, the optimum number of cycles of 177Lu-PSMA in patients who show good response remains unknown. Some patients may benefit from more than 6 cycles of therapy. Additionally, some patients experience a complete or almost complete response before the last cycle. It is unclear whether these patients benefit from the subsequent remaining treatment cycle(s). A treatment holiday period would spare these patients some exposure to the therapy agent and avoid potentially unnecessary toxicity when treatment efficacy is already maximal and additional treatment effect cannot be expected. This randomized phase 2 study compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including \"treatment holiday\" periods (investigational arm, up to 12 cycles, as described below) to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks. The flexible dosing schedule in the investigational arm will be based on single photon emission computed tomography (SPECT)\u002Fcomputed tomography (CT) response assessments obtained 24h after injection of LuPSMA therapy cycle. The response assessment during treatment holiday period will be based on positron emission tomography\u002Fcomputed tomography (PET\u002FCT) every 12 weeks. Single-time point SPECT\u002FCT dosimetry protocol at every cycle will be performed and will allow to determine the number of cycles that subjects may receive under the study without exceeding the kidney dose threshold.",[181,182],"Prostate Carcinoma","Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2026-03-06",{"date":185,"type":186},"2026-03-10","ACTUAL",{"date":188,"type":186},"2024-08-01",{"date":190,"type":175},"2028-12-31",{"name":5,"class":6},1]