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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Xaluritamig will be administered IV.
Abiraterone acetate will be administered orally.
Docetaxel will be administered IV.
OS
Time frame: Up to approximately 51 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment
Time frame: Up to approximately 51 months
Objective Response per Modified RECIST 1.1, Per Investigator Assessment
Time frame: Up to approximately 51 months
Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment
Time frame: Up to approximately 51 months
Disease Control Per Modified RECIST 1.1, Per Investigator Assessment
Time frame: Up to approximately 51 months
Progression-free Survival (PFS) 2, Per Investigator Assessment
Time frame: Up to approximately 51 months
Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment
Time frame: Up to approximately 51 months
Time to First Subsequent Therapy
Time frame: Up to approximately 51 months
Time to Symptomatic Skeletal Events (SSE)
Time frame: Up to approximately 51 months
Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events
Time frame: Up to approximately 51 months
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Cabazitaxel will be administered IV.
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
RECRUITINGProvidence Saint Jude Medical Center
Fullerton, California, United States
RECRUITINGRocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGHightower Clinical
Oklahoma City, Oklahoma, United States
RECRUITINGUnited States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
RECRUITINGUS Oncology Research Investigational Products Center
Tyler, Texas, United States
RECRUITINGUniversity of Virginia Cancer Center
Charlottesville, Virginia, United States
RECRUITING...and 69 more locations
Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale
Time frame: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score
Time frame: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale
Time frame: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Scores
Time frame: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Time frame: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)
Time frame: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Worst Pain Score
Time frame: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Intensity Scale
Time frame: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Interference Scale
Time frame: Up to approximately 51 months
Time to Worsening as Measured by FACT-P Total Score
Time frame: Up to approximately 51 months
Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline
Time frame: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score
Time frame: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score
Time frame: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by Selected Questions on Symptomatic Adverse Events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Time frame: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by the GP5 Question on Overall Bother of Side Effects from the FACT-P Questionnaire
Time frame: Up to approximately 51 months
Prostate-specific Antigen (PSA) 50 and PSA 90 Responses
Time frame: Up to approximately 51 months
Time to PSA 50 and PSA 90 Response
Time frame: Up to approximately 51 months
Duration of PSA 50 and PSA 90 Response
Time frame: Up to approximately 51 months
Time to PSA Progression
Time frame: Up to approximately 51 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 51 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Time frame: Up to approximately 51 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Time frame: Up to approximately 51 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Time frame: Up to approximately 51 months
Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig
Time frame: Up to approximately 51 months
Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 51 months
Abiraterone Serum Concentrations
Time frame: Up to approximately 51 months
Number of Participants with Formation of Anti-xaluritamig Antibodies
Time frame: Up to approximately 51 months