Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
Prostate Cancer, Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer, Xaluritamig, Abiraterone, Abiraterone Acetate, Docetaxel, Cabazitaxel
Brief 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).
Interventions
DRUGXaluritamig
Xaluritamig will be administered IV.
DRUGAbiraterone acetate
Abiraterone acetate will be administered orally.
DRUGDocetaxel
Docetaxel will be administered IV.
DRUGCabazitaxel
Cabazitaxel will be administered IV.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ 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 (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment. * Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria: * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL. * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions. * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria). * Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required. * Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Adequate organ function.
Exclusion criteria
Disease Related: * Participants with a history of central nervous system (CNS) metastases. * Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor. Prior/Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Prior disease progression on or intolerance to abiraterone. * Prior treatment with any chemotherapy regimen in the mCRPC setting and/or \> 6 cycles of docetaxel treatment in the mHSPC setting. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions: * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment. * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]) is permitted. * Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment. * Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment. * Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. * Prior CD3-directed therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS | Up to approximately 51 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Up to approximately 51 months |
| Objective Response per Modified RECIST 1.1, Per Investigator Assessment | Up to approximately 51 months |
| Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment | Up to approximately 51 months |
| Disease Control Per Modified RECIST 1.1, Per Investigator Assessment | Up to approximately 51 months |
| Progression-free Survival (PFS) 2, Per Investigator Assessment | Up to approximately 51 months |
| Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment | Up to approximately 51 months |
| Time to First Subsequent Therapy | Up to approximately 51 months |
| Time to Symptomatic Skeletal Events (SSE) | Up to approximately 51 months |
| Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events | Up to approximately 51 months |
| Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale | Up to approximately 51 months |
| Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score | Up to approximately 51 months |
| Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale | 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 | 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 | Up to approximately 51 months |
| Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS) | Up to approximately 51 months |
| Time to Worsening as Measured by BPI-SF Worst Pain Score | Up to approximately 51 months |
| Time to Worsening as Measured by BPI-SF Pain Intensity Scale | Up to approximately 51 months |
| Time to Worsening as Measured by BPI-SF Pain Interference Scale | Up to approximately 51 months |
| Time to Worsening as Measured by FACT-P Total Score | Up to approximately 51 months |
| Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline | Up to approximately 51 months |
| Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score | Up to approximately 51 months |
| Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score | 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 | 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 | Up to approximately 51 months |
| Prostate-specific Antigen (PSA) 50 and PSA 90 Responses | Up to approximately 51 months |
| Time to PSA 50 and PSA 90 Response | Up to approximately 51 months |
| Duration of PSA 50 and PSA 90 Response | Up to approximately 51 months |
| Time to PSA Progression | Up to approximately 51 months |
| Maximum Serum Concentration (Cmax) of Xaluritamig | Up to approximately 51 months |
| Time to Maximum Concentration (Tmax) of Xaluritamig | Up to approximately 51 months |
| Minimum Serum Concentration (Cmin) of Xaluritamig | Up to approximately 51 months |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig | Up to approximately 51 months |
| Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig | Up to approximately 51 months |
| Half-life (t1/2) of Xaluritamig | Up to approximately 51 months |
| Abiraterone Serum Concentrations | Up to approximately 51 months |
| Number of Participants with Formation of Anti-xaluritamig Antibodies | Up to approximately 51 months |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed