[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637445":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":56,"studyPopulation":45,"armGroups":57,"interventions":76,"overallOfficials":45,"centralContacts":122,"locations":128,"responsibleParty":1176,"collaborators":45,"id":1178,"slug":1179,"hasResults":1180,"nctId":1181,"briefTitle":1182,"officialTitle":1183,"acronym":1184,"eligibilityCriteria":1185,"healthyVolunteers":1180,"sex":1186,"minAge":1187,"maxAge":45,"enrollmentInfo":1188,"targetDuration":45,"studyType":1191,"phases":1192,"briefSummary":1194,"conditions":1195,"keywords":1197,"overallStatus":131,"whyStopped":45,"lastUpdateSubmitDate":1199,"lastUpdatePostDateStruct":1200,"startDateStruct":1203,"completionDateStruct":1205,"leadSponsor":1207,"locationsCount":1208},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"Radiographic Progression-Free Survival (rPFS)","rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and\u002For PCWG3 criteria (bone), or death due to any cause.","From randomization until first radiographic progression per RECIST 1.1\u002FPCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)",{"measure":14,"description":15,"timeFrame":16},"Overall Survival (OS)","OS is defined as the length of time from randomisation until the date of death due to any cause.","From randomization until death from any cause (up to approximately 33 months)",[18,22,26,29,33,37,41],{"measure":19,"description":20,"timeFrame":21},"Progression-Free Survival (PFS)","PFS is defined as the time from randomisation to the earliest of progression (defined as radiographic progression assessed by BICR per RECIST 1.1 and\u002For PCWG3 criteria, clinical progression, or PSA progression), or death due to any cause.","From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)",{"measure":23,"description":24,"timeFrame":25},"Assessment of PSA50 (≥50% prostate-specific antigen reduction)","Proportion of participants achieving a \\>= 50% decrease in PSA from baseline.","From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1\u002FPCWG3 (up to approximately 33 months)",{"measure":27,"description":28,"timeFrame":25},"Assessment of PSA90 (≥90% prostate-specific antigen reduction)","Proportion of participants achieving \\>=90% decrease in PSA from baseline.",{"measure":30,"description":31,"timeFrame":32},"Objective Response Rate (ORR)","ORR is defined as the proportion of participants with measurable soft tissue disease at baseline who have a CR or PR as determined by BICR, per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone).","From baseline; assessed by BICR per RECIST 1.1\u002FPCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)",{"measure":34,"description":35,"timeFrame":36},"Duration of Response (DoR)","DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 (soft tissue) and\u002For PCWG3 criteria (bone) as determined by BICR or death in the absence of disease progression.","From first documented response until progression per RECIST 1.1\u002FPCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)",{"measure":38,"description":39,"timeFrame":40},"Symptomatic Skeletal Event-Free Survival (SSE-FS)","SSE-FS is defined as the time from randomisation to the earliest of the following:\n\n* Use of radiation therapy to prevent or relieve skeletal symptoms.\n* Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).\n* Occurrence of spinal cord compression.\n* Orthopaedic surgical intervention for bone metastasis.\n* Death due to any cause.","From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)",{"measure":42,"description":43,"timeFrame":44},"Plasma concentrations of AZD2265","Plasma concentrations of AZD2265 pre-dose and post-dose.","Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","Participants are randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223).","TREATMENT",{"masking":52,"maskingDescription":53,"whoMasked":54},"SINGLE","Open-label",[55],"OUTCOMES_ASSESSOR","Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death.\n\nAll patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Arm A","EXPERIMENTAL","Actinium (225Ac) zadavotide guraxetan (AZD2265 \\[FPI-2265\\])",[63],"Drug: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])",{"label":65,"type":66,"description":67,"interventionNames":68},"Arm B","ACTIVE_COMPARATOR","Investigator's choice of cabazitaxel, ARPI, or radium-223",[69,70,71,72,73,74,75],"Drug: Cabazitaxel","Drug: Abiraterone","Drug: Enzalutamide","Drug: Apalutamide","Drug: Darolutamide","Drug: Deutenzalutamide","Drug: Radium-223",[77,84,90,96,102,108,113,117],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])","IV",[59],[83],"AZD2265, 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mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and\u002For non-measurable) that is suitable for repeated assessment by CT and\u002For MRI and\u002For bone scan.\n* Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.\n* Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.\n* Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).\n* Positive PSMA PET\u002FCT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).\n* ECOG performance status of 0 to 2.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).\n* Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.\n* Receipt of \\> 6 cycles of PSMA-directed β-emitting therapeutic RC.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Clinically significant ECG abnormalities, with exceptions.","MALE","18 Years",{"count":1189,"type":1190},670,"ESTIMATED","INTERVENTIONAL",[1193],"PHASE3","The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.",[1196],"Metastatic Castration-resistant Prostate Cancer",[1198],"AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac; Actinium (225Ac) zadavotide guraxetan","2026-08-24",{"date":1201,"type":1202},"2026-08-26","ACTUAL",{"date":1204,"type":1202},"2026-05-04",{"date":1206,"type":1190},"2030-06-06",{"name":5,"class":6},132]