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 \[ARDT\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
675
Overall Survival (OS)
Time frame: Up to approximately 53 months
Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 53 months
Objective Response Rate per Modified RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 53 months
Duration of Response (DOR) per Modified RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 53 months
Disease Control Rate per Modified RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 53 months
Time to Response (TTR) per Modified RECIST v1.1 as Assessed by BICR
Time frame: Up to approximately 53 months
Time to First Symptomatic Skeletal Events (SSE)
Time frame: Up to approximately 53 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 53 months
Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score
Time frame: Baseline and approximately 53 months
Change from Baseline in BPI-SF Pain Intensity Scale Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IV infusion
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGProvidence Saint Jude Medical Center
Fullerton, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California Irvine
Orange, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Florida, College of Medicine
Gainesville, Florida, United States
RECRUITINGSylvester Comprehensive Cancer Center-Fox Building
Miami, Florida, United States
RECRUITINGAdventHealth Orlando
Orlando, Florida, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITING...and 154 more locations
Time frame: Baseline and approximately 53 months
Change from Baseline in BPI-SF Pain Interference Scale Score
Time frame: Baseline and approximately 53 months
Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Time frame: Baseline and approximately 53 months
Change from baseline in the EQ-5D-5L Visual Analogue Scale (VAS)
Time frame: Baseline and approximately 53 months
Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Score
Time frame: Baseline and approximately 53 months
Time to Worsening in BPI-SF Worst Pain Score
Time frame: Up to approximately 53 months
Time to Worsening in BPI-SF Pain Intensity Scale Score
Time frame: Up to approximately 53 months
Time to Worsening in BPI-SF Pain Interference Scale Score
Time frame: Up to approximately 53 months
Time to Worsening in FACT-P Total Score
Time frame: Up to approximately 53 months
Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline
Time frame: Up to approximately 53 months
Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score
Time frame: Up to approximately 53 months
Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale
Time frame: Up to approximately 53 months
Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Time frame: Up to approximately 53 months
Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P
Time frame: Up to approximately 53 months
Percentage of Participants Achieving a ≥50% Reduction in Prostate-specific Antigen (PSA) (PSA50)
Time frame: Up to approximately 53 months
Percentage of Participants Achieving a ≥90% Reduction in PSA (PSA90)
Time frame: Up to approximately 53 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 53 months
Time to Cmax (Tmax) of Xaluritamig
Time frame: Up to approximately 53 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Time frame: Up to approximately 53 months
Area Under the Concentration-time Curve (AUC) of Xaluritamig
Time frame: Up to approximately 53 months
Accumulation Following Multiple Dosing of Xaluritamig
Time frame: Up to approximately 53 months
Half-life (t1/2) of Xaluritamig
Time frame: Up to approximately 53 months
Number of Participants with Anti-xaluritamig Antibody
Time frame: Up to approximately 53 months