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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06691984




Registration number
NCT06691984
Ethics application status
Date submitted
14/11/2024
Date registered
18/11/2024

Titles & IDs
Public title
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy
Secondary ID [1] 0 0
2024-513968-25
Secondary ID [2] 0 0
20230005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xaluritamig
Treatment: Drugs - Abiraterone
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Cabazitaxel

Experimental: Xaluritamig - Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.

Active comparator: Cabazitaxel/Abiraterone/Enzalutamide - Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion.


Treatment: Drugs: Xaluritamig
Short-term IV infusion

Treatment: Drugs: Abiraterone
Oral tablets

Treatment: Drugs: Enzalutamide
Oral tablets

Treatment: Drugs: Cabazitaxel
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [1] 0 0
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)
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [2] 0 0
Objective Response Rate per RECIST v1.1 as Assessed by BICR
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to approximately 43 months
Secondary outcome [3] 0 0
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to approximately 43 months
Secondary outcome [4] 0 0
Disease Control Rate
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to approximately 43 months
Secondary outcome [5] 0 0
Progression-free Survival (PFS)
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to approximately 43 months
Secondary outcome [6] 0 0
Time to Response (TTR) per RECIST v1.1 as Assessed by BICR
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to approximately 43 months
Secondary outcome [7] 0 0
Time to First Symptomatic Skeletal Events (SSE)
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to approximately 43 months
Secondary outcome [8] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Assessment method [8] 0 0
Timepoint [8] 0 0
Up to approximately 43 months
Secondary outcome [9] 0 0
Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score
Assessment method [9] 0 0
Timepoint [9] 0 0
Baseline and approximately 43 months
Secondary outcome [10] 0 0
Change from Baseline in BPI-SF Pain Intensity Scale Score
Assessment method [10] 0 0
Timepoint [10] 0 0
Baseline and approximately 43 months
Secondary outcome [11] 0 0
Change from Baseline in BPI-SF Pain Interference Scale Score
Assessment method [11] 0 0
Timepoint [11] 0 0
Baseline and approximately 43 months
Secondary outcome [12] 0 0
Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Visual Analogue Scale (VAS)
Assessment method [12] 0 0
Timepoint [12] 0 0
Baseline and approximately 43 months
Secondary outcome [13] 0 0
Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score
Assessment method [13] 0 0
Timepoint [13] 0 0
Baseline and approximately 43 months
Secondary outcome [14] 0 0
Time to Worsening in BPI-SF Worst Pain Score
Assessment method [14] 0 0
Timepoint [14] 0 0
Up to approximately 43 months
Secondary outcome [15] 0 0
Time to Worsening in BPI-SF Pain Intensity Scale Score
Assessment method [15] 0 0
Timepoint [15] 0 0
Up to approximately 43 months
Secondary outcome [16] 0 0
Time to Worsening in BPI-SF Pain Interference Scale Score
Assessment method [16] 0 0
Timepoint [16] 0 0
Up to approximately 43 months
Secondary outcome [17] 0 0
Time to Worsening in FACT-P Total Score
Assessment method [17] 0 0
Timepoint [17] 0 0
Up to approximately 43 months
Secondary outcome [18] 0 0
Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline
Assessment method [18] 0 0
Timepoint [18] 0 0
Up to approximately 43 months
Secondary outcome [19] 0 0
Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score
Assessment method [19] 0 0
Timepoint [19] 0 0
Up to approximately 43 months
Secondary outcome [20] 0 0
Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale
Assessment method [20] 0 0
Timepoint [20] 0 0
Up to approximately 43 months
Secondary outcome [21] 0 0
Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Assessment method [21] 0 0
Timepoint [21] 0 0
Up to approximately 43 months
Secondary outcome [22] 0 0
Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P
Assessment method [22] 0 0
Timepoint [22] 0 0
Up to approximately 43 months
Secondary outcome [23] 0 0
Percentage of Participants Achieving a =50% Reduction in Prostate-specific Antigen (PSA) (PSA50)
Assessment method [23] 0 0
Timepoint [23] 0 0
Up to approximately 43 months
Secondary outcome [24] 0 0
Percentage of Participants Achieving a =90% Reduction in PSA (PSA90)
Assessment method [24] 0 0
Timepoint [24] 0 0
Up to approximately 43 months
Secondary outcome [25] 0 0
Maximum Serum Concentration (Cmax) of Xaluritamig
Assessment method [25] 0 0
Timepoint [25] 0 0
Up to approximately 43 months
Secondary outcome [26] 0 0
Time to Cmax (Tmax) of Xaluritamig
Assessment method [26] 0 0
Timepoint [26] 0 0
Up to approximately 43 months
Secondary outcome [27] 0 0
Minimum Serum Concentration (Cmin) of Xaluritamig
Assessment method [27] 0 0
Timepoint [27] 0 0
Up to approximately 43 months
Secondary outcome [28] 0 0
Area Under the Concentration-time Curve (AUC) of Xaluritamig
Assessment method [28] 0 0
Timepoint [28] 0 0
Up to approximately 43 months
Secondary outcome [29] 0 0
Accumulation Following Multiple Dosing of Xaluritamig
Assessment method [29] 0 0
Timepoint [29] 0 0
Up to approximately 43 months
Secondary outcome [30] 0 0
Half-life (t1/2) of Xaluritamig
Assessment method [30] 0 0
Timepoint [30] 0 0
Up to approximately 43 months
Secondary outcome [31] 0 0
Number of Participants with Anti-xaluritamig Antibody
Assessment method [31] 0 0
Timepoint [31] 0 0
Up to approximately 43 months

Eligibility
Key inclusion criteria
* Participant has provided informed consent prior to 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.
* 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 prior to enrollment.
* Evidence of progressive disease, defined as 1 or more PCWG3 criteria:

* Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal 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 one or more new lesions.
* Progression of bone disease: evaluable disease or new bone lesion(s) by bone scan (2+2 PCWG3 criteria, Scher et al, 2016).
* Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
* Prior treatment with at least one ARDT.
* Prior treatment with one taxane therapy. Prior treatment with docetaxel in the hormone-sensitive setting is permitted. Participants who received two or more prior chemotherapy regimens in the castrate-resistant setting are not eligible.
* Prior treatment with radioligand therapy (RLT), radionuclide therapy (Radium-223), poly ADP-ribose polymerase (PARP) inhibitor, or immune checkpoint inhibitor is permitted.
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
* Adequate organ function.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior & Concomitant Therapy:

* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen suppression therapy.
* Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 2 months of the first dose of study treatment unless participants received < 2 cycles of therapy. Participants who received 1 cycle of PSMA RLT within 35 days prior to the first dose of study treatment are also excluded.
* Participants who started a bisphosphonate or denosumab regimen within 4 weeks prior to the first dose of study treatment.
* Radiation therapy within 4 weeks prior to the first dose of study treatment (or local or focal radiotherapy within 2 weeks prior to the first dose of study treatment).
* Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy.

Disease Related:

* Participants with a history of central nervous system (CNS) metastasis.
* Unresolved toxicities from prior anti-tumor therapy with CTCAE version 5.0 events grade above 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/05/2030
Actual
Sample size
Target
675
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Macquarie University - North Ryde
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
The Alfred Hospital - Warrnambool
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Japan
State/province [11] 0 0
Aichi
Country [12] 0 0
Japan
State/province [12] 0 0
Ehime
Country [13] 0 0
Japan
State/province [13] 0 0
Hokkaido
Country [14] 0 0
Japan
State/province [14] 0 0
Kanagawa
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daejeon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Goyang-si, Gyeonggi-do
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seongnam-si, Gyeonggi-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Glasgow
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06691984