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Bern","Bern","3010","Switzerland","CH",{"type":63,"coordinates":1256},[1257,1258],7.44744,46.94809,{"lat":1258,"lon":1257},{"facility":1261,"status":56,"city":1262,"state":34,"zip":1263,"country":1253,"countryCode":1254,"cosmosGeoPoint":1264,"geoPoint":1268,"contacts":34},"Centre Hospitalier Universitaire Vaudois","Lausanne","1011",{"type":63,"coordinates":1265},[1266,1267],6.63282,46.516,{"lat":1267,"lon":1266},{"facility":1270,"status":56,"city":1271,"state":34,"zip":1272,"country":1253,"countryCode":1254,"cosmosGeoPoint":1273,"geoPoint":1277,"contacts":34},"Kantonsspital Sankt Gallen","Sankt Gallen","9007",{"type":63,"coordinates":1274},[1275,1276],9.37477,47.42391,{"lat":1276,"lon":1275},{"facility":1279,"status":56,"city":1280,"state":34,"zip":1281,"country":1253,"countryCode":1254,"cosmosGeoPoint":1282,"geoPoint":1286,"contacts":34},"Hirslanden Zurich","Zurich","8032",{"type":63,"coordinates":1283},[1284,1285],8.55,47.36667,{"lat":1285,"lon":1284},{"facility":1288,"status":56,"city":1289,"state":34,"zip":1290,"country":1291,"countryCode":1292,"cosmosGeoPoint":1293,"geoPoint":1297,"contacts":34},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","80756","Taiwan","TW",{"type":63,"coordinates":1294},[1295,1296],120.31333,22.61626,{"lat":1296,"lon":1295},{"facility":1299,"status":56,"city":1300,"state":34,"zip":1301,"country":1291,"countryCode":1292,"cosmosGeoPoint":1302,"geoPoint":1306,"contacts":34},"Taichung Veterans General Hospital","Taichung","40705",{"type":63,"coordinates":1303},[1304,1305],120.6839,24.1469,{"lat":1305,"lon":1304},{"facility":1308,"status":56,"city":1309,"state":34,"zip":1310,"country":1291,"countryCode":1292,"cosmosGeoPoint":1311,"geoPoint":1315,"contacts":34},"National Cheng Kung University Hospital","Tainan","70403",{"type":63,"coordinates":1312},[1313,1314],120.21333,22.99083,{"lat":1314,"lon":1313},{"facility":1317,"status":56,"city":1318,"state":34,"zip":1319,"country":1291,"countryCode":1292,"cosmosGeoPoint":1320,"geoPoint":1324,"contacts":34},"National Taiwan University Hospital","Taipei","10002",{"type":63,"coordinates":1321},[1322,1323],121.52639,25.05306,{"lat":1323,"lon":1322},{"facility":1326,"status":56,"city":1327,"state":34,"zip":1328,"country":1329,"countryCode":1330,"cosmosGeoPoint":1331,"geoPoint":1335,"contacts":34},"Guys Hospital","London","SE1 9RY","United Kingdom","UK",{"type":63,"coordinates":1332},[1333,1334],-0.12574,51.50853,{"lat":1334,"lon":1333},{"facility":1337,"status":56,"city":1327,"state":34,"zip":1338,"country":1329,"countryCode":1330,"cosmosGeoPoint":1339,"geoPoint":1341,"contacts":34},"Sarah Cannon Research Institute UK","W1G 6AD",{"type":63,"coordinates":1340},[1333,1334],{"lat":1334,"lon":1333},{"facility":1343,"status":56,"city":1344,"state":34,"zip":1345,"country":1329,"countryCode":1330,"cosmosGeoPoint":1346,"geoPoint":1350,"contacts":34},"Royal Marsden Hospital","Sutton","SM2 5PT",{"type":63,"coordinates":1347},[1348,1349],-0.2,51.35,{"lat":1349,"lon":1348},{"type":1352,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100609368","phase-3-a-study-of-xaluritamig-plus-abiraterone-versus-investigators-choice-in-participants-with-chemotherapy-nave-metastatic-castration-resistant-prostate-cancer-100609368",false,"NCT07213674","A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participant must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.\n* Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:\n\n  * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).\n* Participants must have had prior orchiectomy and\u002For ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.\n* Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\nDisease Related:\n\n* Participants with a history of central nervous system (CNS) metastases.\n* Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n\nPrior\u002FConcomitant Therapy:\n\n* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior disease progression on or intolerance to abiraterone.\n* Prior treatment with any chemotherapy regimen in the mCRPC setting and\u002For \\> 6 cycles of docetaxel treatment in the mHSPC setting.\n* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:\n\n  * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.\n  * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone\u002Fgonadotrophin releasing hormone \\[LHRH\u002FGnRH\\] analogue \\[agonist\u002Fantagonist\\]) is permitted.\n* Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.\n* Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.\n* Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.\n* Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.\n* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.\n* Prior CD3-directed therapy.","MALE","18 Years",{"count":1363,"type":1364},750,"ESTIMATED","INTERVENTIONAL",[1367],"PHASE3","The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).",[1370],"Metastatic Castration-resistant Prostate Cancer",[1372,1373,25,1374,1375,36,40],"Prostate Cancer","Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Abiraterone","Abiraterone Acetate","2026-08-20",{"date":1378,"type":1379},"2026-08-21","ACTUAL",{"date":1381,"type":1379},"2025-11-28",{"date":1383,"type":1364},"2032-08-30",{"name":5,"class":6},150]