Actively Recruiting
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Led by Amgen · Updated on 2026-05-14
750
Participants Needed
127
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent before any study procedures
- Age 18 years or older at the time of consent
- Histological, pathological, or cytological confirmation of prostate adenocarcinoma
- Metastatic castration-resistant prostate cancer with at least one metastatic lesion visible on CT, MRI, or bone scan within 28 days before enrollment
- Evidence of progressive disease by PCWG3-modified RECIST 1.1 criteria, including PSA progression, soft-tissue progression, or bone disease progression
- Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum testosterone levels (< 50 ng/dL or < 1.7 nmol/L)
- Prior disease progression on exactly one androgen receptor pathway inhibitor (enzalutamide, apalutamide, or darolutamide)
- Participants intended for cabazitaxel must have received up to 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- History of central nervous system (CNS) metastases
- Unresolved toxicities from prior antitumor therapy not resolved to grade 1 or baseline, except stable and well-controlled alopecia or other toxicities allowed by investigator and sponsor
- Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy
- Prior disease progression on or intolerance to abiraterone
- Prior chemotherapy in the metastatic castration-resistant prostate cancer setting or more than 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer setting
- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before study treatment, except allowed androgen receptor pathway inhibitors with minimum 2 weeks washout and androgen suppression therapy
- Prior radioligand therapy within 8 weeks before study treatment
- Prior radionuclide therapy (radium-223) within 2 months before study treatment
- Prior palliative radiotherapy within 2 weeks before study treatment unless fully recovered from radiation-related toxicities
- Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, radioligand therapy, PARP inhibitors, biological therapy, or investigational therapy
- Treatment with live or live-attenuated vaccines within 4 weeks before study treatment
- Prior CD3-directed therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 127 locations
1
City of Hope Cancer Center Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
Providence Saint Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
5
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
6
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
7
City of Hope Atlanta
Newnan, Georgia, United States, 30265
Actively Recruiting
8
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
9
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
10
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
11
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
12
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
13
Barbara Ann Karmanos Cancer Institute
Lansing, Michigan, United States, 48910
Actively Recruiting
14
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Hematology Oncology Association of Central New York
East Syracuse, New York, United States, 13057
Actively Recruiting
16
Oncology Hematology Care Incorporated
Cincinnati, Ohio, United States, 45242
Actively Recruiting
17
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Actively Recruiting
18
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
19
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States, 37203
Actively Recruiting
20
The Center for Cancer and Blood Disorders
Arlington, Texas, United States, 76012
Actively Recruiting
21
Texas Oncology Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
22
US Oncology Research Investigational Products Center
Tyler, Texas, United States, 75702
Actively Recruiting
23
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
24
Virginia Cancer Specialists PC
Leesburg, Virginia, United States, 20176
Actively Recruiting
25
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
26
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298
Actively Recruiting
27
Icon Cancer Care Wesley
Herston, Queensland, Australia, 4029
Actively Recruiting
28
Tasman Oncology Research
Southport, Queensland, Australia, 4215
Actively Recruiting
29
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
30
Austin Health, Austin Hospital
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
31
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Actively Recruiting
32
Universitaetsklinikum Sankt Poelten
Sankt Pölten, Austria, 3100
Actively Recruiting
33
Krankenhaus der Barmherzigen Brueder Wien
Vienna, Austria, 1020
Actively Recruiting
34
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Actively Recruiting
35
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
36
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
37
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
38
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
Yvoir, Belgium, 5530
Actively Recruiting
39
Centre de Recherche du Centre Hospitalier de l Universite de Montreal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
40
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
41
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, France, 33075
Actively Recruiting
42
Centre Regional Francois Baclesse
Caen, France, 14076
Actively Recruiting
43
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
44
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
45
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
46
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
47
Groupe Hospitalier Paris Saint Joseph
Paris, France, 75014
Actively Recruiting
48
Hopital Europeen Georges Pompidou
Paris, France, 75015
Actively Recruiting
49
Hopital Foch
Suresnes, France, 92151
Actively Recruiting
50
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
51
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
52
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
53
Universitaetsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
54
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
55
Uniklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
56
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
57
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
58
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
59
Universitatsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
60
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, Germany, 24105
Actively Recruiting
61
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
62
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97080
Actively Recruiting
63
University General Hospital of Alexandroupoli
Alexandroupoli, Greece, 68100
Actively Recruiting
64
Henry Dunant Hospital Center
Athens, Greece, 11526
Actively Recruiting
65
Alexandra Hospital
Athens, Greece, 11528
Actively Recruiting
66
Attikon University Hospital
Athens, Greece, 12462
Actively Recruiting
67
University Hospital of Heraklion
Heraklion - Crete, Greece, 71500
Actively Recruiting
68
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
Kifissia, Athens, Greece, 14564
Actively Recruiting
69
Athens Medical Center S.A - Iatriko Amarousiou
Marousi, Greece, 15125
Actively Recruiting
70
European Interbalkan Medical Center
Thessaloniki, Greece, 57001
Actively Recruiting
71
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, Italy, 71122
Actively Recruiting
72
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
73
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
74
Azienda Ospedaliera Universitaria di Modena Policlinico
Modena, Italy, 41124
Actively Recruiting
75
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
76
Ospedale Pederzoli Casa di Cura Privata
Peschiera del Garda, Italy, 37019
Actively Recruiting
77
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
78
Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino
Trento, Italy, 38122
Actively Recruiting
79
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
80
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
81
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
82
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
83
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
84
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan, 761-0793
Actively Recruiting
85
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan, 252-0375
Actively Recruiting
86
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
87
The University of Osaka Hospital
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
88
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan, 350-1298
Actively Recruiting
89
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan, 343-8555
Terminated
90
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
91
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
92
The Jikei University Hospital
Minato-ku, Tokyo, Japan, 105-8471
Actively Recruiting
93
Toyama University Hospital
Toyama, Toyama, Japan, 930-0194
Actively Recruiting
94
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
95
Hospital da Luz, SA
Lisbon, Portugal, 1500-650
Actively Recruiting
96
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
97
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Actively Recruiting
98
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, Portugal, 4200-319
Actively Recruiting
99
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, Portugal, 4430-502
Actively Recruiting
100
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
101
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
102
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
103
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
104
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
105
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
106
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, Spain, 29010
Actively Recruiting
107
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain, 29011
Actively Recruiting
108
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
109
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
110
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
111
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, Spain, 15006
Actively Recruiting
112
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain, 27003
Actively Recruiting
113
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
114
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
115
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
116
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
117
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
118
Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
119
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
120
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
121
Hirslanden Zurich
Zurich, Switzerland, 8032
Actively Recruiting
122
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
123
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
124
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
125
Guys Hospital
London, United Kingdom, SE1 9RY
Actively Recruiting
126
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
127
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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