A Phase 3 interventional study of Xaluritamig and Abiraterone acetate in Metastatic Castration-resistant Prostate Cancer, sponsored by Amgen. Recruiting at 159 sites in 18 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
Among 22 studies in Prostatic Neoplasms by Amgen — 5 open to participants now, 7 under way, 2 of them phase 3. Prostatic Neoplasms · Amgen.
Among the 22 studies in Prostatic Neoplasms by Amgen, this one is the 4th largest by planned enrollment of the 20 interventional ones, is one of 2 that started in 2025, is one of 9 in phase 3, and was the 21st registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 750 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →5 of the 22 studies in Prostatic Neoplasms by Amgen are open now, in 12 countries. Each count lists the studies.
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 2 started in 2025.
Median enrollment 97 across the 20 interventional studies, 1,262 across the 1 observational. Of the 14 that completed or were terminated, 11 (79%) have results posted.
Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
2 of the studies in Prostatic Neoplasms by Amgen that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06613100AmgenEvaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer | 2027-02-17 |
| NCT06555796AmgenEvaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer | 2027-03-13 |
Among the 22 studies in Prostatic Neoplasms by Amgen, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified 1.1 criteria:
Exclusion Criteria:
Disease Related:
Prior/Concomitant Therapy:
Any anticancer therapy, immunotherapy, or agent within 4 weeks before first dose of study treatment with the following exceptions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
Drug: Xaluritamig · Drug: Abiraterone acetate
Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W.
Drug: Abiraterone acetate · Drug: Docetaxel · Drug: Cabazitaxel
Xaluritamig will be administered IV.
Also known as: AMG 509
Abiraterone acetate will be administered orally.
Docetaxel will be administered IV.
Cabazitaxel 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
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
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 159 sites across 18 countries. Choose a country and city above to see the rest.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Started Nov 2025 (actual). Primary completion is estimated for Jan 2030, 49 months after the start.
Of 126 industry-sponsored phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's planned 49 months is above that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Xaluritamig