Actively Recruiting
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Led by Amgen · Updated on 2026-03-06
675
Participants Needed
164
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).
CONDITIONS
Official Title
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age 63 18 years (or 63 legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- Metastatic castration-resistant prostate cancer with at least 1 metastatic lesion visible on baseline CT, MRI, or bone scan imaging obtained within 28 days prior to enrollment.
- Evidence of progressive disease defined by at least one PCWG3 criterion including PSA progression, soft-tissue progression, or bone disease progression.
- Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate level serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Prior progression on at least one androgen receptor-directed therapy (enzalutamide, abiraterone, apalutamide, darolutamide).
- Prior treatment with only one taxane therapy in the metastatic castration-resistant prostate cancer setting.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function.
- Life expectancy of at least 12 weeks as assessed by the treating physician.
You will not qualify if you...
- Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
- Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to first dose of study treatment, excluding androgen receptor pathway inhibitors which require a 2-week washout.
- Prior Prostate-Specific Membrane Antigen radioligand therapy within 3 months unless fewer than 2 cycles were received.
- Prior palliative radiotherapy within 2 weeks of first dose; participant must have recovered from all radiation-related toxicities.
- Concurrent cytotoxic chemotherapy, androgen receptor-directed therapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy, except prior PARP inhibitor if not within 4 weeks of first dose.
- Prior radionuclide therapy (Radium-223) within 2 months of first dose.
- Treatment with live or live-attenuated vaccines within 4 weeks before first dose.
- History of central nervous system metastasis, except for treated, asymptomatic, and clinically stable dural metastases.
- Unresolved toxicities from prior anti-tumor therapy not resolved to grade 1 or baseline, except alopecia or stable, well-controlled toxicities with investigator and sponsor agreement.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 164 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
Providence Saint Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
4
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
7
University of Florida, College of Medicine
Gainesville, Florida, United States, 32610
Actively Recruiting
8
Sylvester Comprehensive Cancer Center-Fox Building
Miami, Florida, United States, 33136
Actively Recruiting
9
AdventHealth Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
10
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
11
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
12
University of Louisville Health - James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
13
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
17
Henry Ford Hospital, Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Actively Recruiting
18
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
19
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
20
Yale New Haven Hospital
New York, New York, United States, 10032
Actively Recruiting
21
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
22
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
23
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
24
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
25
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
26
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
27
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
28
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
29
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
30
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
31
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
32
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
33
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
34
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
35
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
36
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
37
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
38
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
39
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98019-1024
Actively Recruiting
40
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
41
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
42
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
43
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
44
Macquarie University
North Ryde, New South Wales, Australia, 2109
Actively Recruiting
45
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
46
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
47
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
48
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
49
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
50
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
51
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4010
Actively Recruiting
52
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Actively Recruiting
53
Universitaetsklinikum Sankt Poelten
Sankt Pölten, Austria, 3100
Actively Recruiting
54
Krankenhaus der Barmherzigen Brueder Wien
Vienna, Austria, 1020
Actively Recruiting
55
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Actively Recruiting
56
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Actively Recruiting
57
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
58
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, Belgium, 8500
Actively Recruiting
59
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
60
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
61
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
62
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
63
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
64
CHU de Quebec-Universite Laval
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
65
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
66
Vejle Sygehus
Vejle, Denmark, 7100
Actively Recruiting
67
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, France, 33075
Actively Recruiting
68
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
69
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
La Tronche, France, 38700
Actively Recruiting
70
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Actively Recruiting
71
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
72
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
73
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
74
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
75
Hopital d Instruction des Armees - Hopital Begin
Saint-Mandé, France, 94163
Actively Recruiting
76
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
77
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
78
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
79
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
80
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
81
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
82
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
83
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
84
Universitaetsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
85
Universitaetsklinikum Schleswig-Holstein - Luebeck
Lübeck, Germany, 23538
Actively Recruiting
86
Klinikum rechts der Isar der TUM
München, Germany, 81675
Actively Recruiting
87
Universitaetsklinikum Muenster
Münster, Germany, 48149
Actively Recruiting
88
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97078
Actively Recruiting
89
Alexandra Hospital
Athens, Greece, 11528
Actively Recruiting
90
Athens Medical Center S.A - Iatriko Amarousiou
Athens, Greece, 15125
Actively Recruiting
91
Metropolitan General
Athens, Greece, 15562
Actively Recruiting
92
Metropolitan Hospital
Athens, Greece, 18547
Actively Recruiting
93
European Interbalkan Medical Center
Thessaloniki, Greece, 57001
Actively Recruiting
94
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
95
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, Italy, 71122
Actively Recruiting
96
Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce
Gallipoli, Italy, 73014
Actively Recruiting
97
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132
Actively Recruiting
98
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
99
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
100
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
101
Ospedale Santa Chiara Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento
Trento, Italy, 38122
Actively Recruiting
102
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
103
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
104
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
105
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
106
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
107
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
108
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan, 252-0375
Actively Recruiting
109
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
110
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
111
The University of Osaka Hospital
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
112
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan, 350-1298
Actively Recruiting
113
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan, 343-8555
Actively Recruiting
114
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
115
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
116
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Actively Recruiting
117
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
118
Reinier de Graaf Gasthuis
Delft, Netherlands, 2625 AD
Actively Recruiting
119
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
120
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
121
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
122
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
123
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Actively Recruiting
124
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
125
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
126
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
127
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
128
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
129
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
130
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
131
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
132
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
133
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain, 29011
Actively Recruiting
134
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
135
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
136
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
137
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
138
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
139
Instituto Valenciano de Oncologia
Valencia, Valencia, Spain, 46009
Actively Recruiting
140
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
141
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
142
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
143
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 413 45
Actively Recruiting
144
Skanes Universitetssjukhus
Lund, Sweden, 221 85
Actively Recruiting
145
Karolinska Universitetssjukhuset
Stockholm, Sweden, 171 76
Actively Recruiting
146
Norrlands Universitetssjukhus
Umeå, Sweden, 901 85
Actively Recruiting
147
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Actively Recruiting
148
Inselspital Bern
Bern, Switzerland, 3010
Actively Recruiting
149
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Actively Recruiting
150
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
151
Kantonsspital Sankt Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
152
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
153
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
154
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
155
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
156
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, Taiwan, 33305
Actively Recruiting
157
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
158
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
159
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey (Türkiye), 35575
Actively Recruiting
160
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
161
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
162
Guys Hospital
London, United Kingdom, SE1 9RY
Actively Recruiting
163
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
164
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here