A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
NCT07213674 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750
Last updated 2026-05-22
Summary
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
Interventions
- DRUG
-
Xaluritamig will be administered IV.
- DRUG
-
Abiraterone acetate
Abiraterone acetate will be administered orally.
- DRUG
-
Docetaxel will be administered IV.
- DRUG
-
Cabazitaxel
Cabazitaxel will be administered IV.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-28
- Primary Completion
- 2030-01-07
- Completion
- 2032-08-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- France
- Germany
- Greece
- Italy
- Japan
- Netherlands
- Portugal
- Singapore
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
NCT07140900 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
NCT01522443 ·Status: TERMINATED ·Phase: PHASE3
-
Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC
NCT01995058 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
NCT01605227 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
NCT04087174 ·Status: COMPLETED ·Phase: PHASE1
-
Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC)
NCT00661492 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
NCT03419234 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.
NCT01972217 ·Status: COMPLETED ·Phase: PHASE2
-
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
NCT01630590 ·Status: COMPLETED ·Phase: PHASE2
-
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
NCT06470243 ·Status: RECRUITING ·Phase: PHASE3
-
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721 ·Status: TERMINATED ·Phase: PHASE2
-
Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
NCT04038502 ·Status: RECRUITING ·Phase: PHASE2
-
Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer
NCT02254785 ·Status: UNKNOWN ·Phase: PHASE2
-
Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer
NCT04272645 ·Status: WITHDRAWN ·Phase: PHASE2
-
AMG 386 and Abiraterone for Advanced Prostate Cancer
NCT01553188 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
NCT03012321 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
NCT05534646 ·Status: RECRUITING ·Phase: PHASE2
-
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
NCT06520345 ·Status: RECRUITING ·Phase: PHASE3
-
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT00887198 ·Status: COMPLETED ·Phase: PHASE3
-
XL-184+Abiraterone in Post-Chemo CRPC
NCT01574937 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
NCT06613100 ·Status: RECRUITING ·Phase: PHASE1
-
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
NCT00638690 ·Status: COMPLETED ·Phase: PHASE3
-
Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT05613894 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
NCT04495179 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
NCT00521781 ·Status: TERMINATED ·Phase: PHASE2