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RecruitingPHASE3INTERVENTIONAL

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

This research study is investigating a new treatment approach for men with advanced prostate cancer that has spread to other parts of the body and is no longer being controlled by standard hormone therapy. This type of cancer is called metastatic castration-resistant prostate cancer (mCRPC). The study is comparing a new drug called Xaluritamig, given along with an existing drug called Abiraterone, to other established treatments like Docetaxel, Cabazitaxel, or Abiraterone alone. The main goal is to see if the Xaluritamig and Abiraterone combination helps men live longer. The study is for men whose cancer hasn't been treated with chemotherapy yet.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Amgen
Enrolment target
750
Start
28 Nov 2025
Estimated completion
30 Aug 2032

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large, important study designed to confirm if a new treatment is effective and safe compared to current treatments. It focuses on men who have prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to hormone therapy (castration-resistant). This is often referred to as mCRPC. Importantly, the men in this study will not have had chemotherapy before.

The main purpose of this study is to see if a new drug combination, Xaluritamig plus Abiraterone, can help men with mCRPC live longer compared to standard treatments. The standard treatments used for comparison in this study could be one of three options: Docetaxel, Cabazitaxel, or Abiraterone by itself. Researchers want to understand if this new combination offers a better outcome for patients.

Finding out if new treatments are better than existing ones is how medicine progresses and improves care for patients. By participating, volunteers are helping medical science learn more about how to treat this type of prostate cancer effectively.

Key takeaways

  • This study is testing a new drug combination for advanced prostate cancer.
  • It's for men whose cancer has spread and is no longer controlled by hormone therapy.
  • Participants have not had chemotherapy yet.
  • The main goal is to see if the new treatment helps men live longer.
  • You might receive the new treatment or a standard treatment.
  • Close medical monitoring is provided throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of prostate cancer that has spread. Your cancer also needs to be resistant to hormone therapy, meaning it's still growing despite hormone treatments. We'll check this by looking at your scans and blood tests to make sure there's evidence your cancer is progressing.

You must have had your testosterone levels lowered, either through surgery or ongoing hormone therapy, and your testosterone levels need to be very low. You also need to have tried one, but only one, specific hormone therapy drug in the past (like enzalutamide, apalutamide, or darolutamide) and your cancer must have progressed while on it. Your health in general should be good enough to participate in a clinical trial. If you are a candidate for cabazitaxel as a treatment option, you should not have received more than 6 cycles of docetaxel before for your cancer when it was hormone-sensitive.

Quick self-check
  • Are you 18 years or older?
  • Do you have prostate cancer that has spread to other parts of your body?
  • Is your prostate cancer no longer responding to hormone therapy?
  • Have you *not* had chemotherapy for your prostate cancer yet?
  • Have you previously taken one specific type of hormone therapy drug (like enzalutamide, apalutamide, or darolutamide) and your cancer progressed while on it?
  • Are your general health and fitness good enough for a clinical trial?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would first go through a screening process to make sure you're a good fit. This might involve blood tests, scans (like CT, MRI, or bone scans), and a review of your medical history. Once enrolled, you would receive either the new drug combination (Xaluritamig plus Abiraterone) or one of the standard treatments. The specific details of how often you would take the medication and attend appointments would be explained by the study team, but generally, there will be regular visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The total length of your participation would depend on how your treatment is progressing and what the study protocol dictates, including follow-up after your treatment.

Potential risks and benefits

Taking part in a clinical trial means you might experience potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks, including side effects from the drugs and the possibility that the new treatment may not be more effective than current ones. All known potential side effects will be fully explained before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (133)

  • City of Hope Cancer Center Phoenix
    Goodyear, United States· Recruiting
  • City of Hope National Medical Center
    Duarte, United States· Recruiting
  • City of Hope Orange County Lennar Foundation Cancer Center
    Duarte, United States· Recruiting
  • Providence Saint Jude Medical Center
    Fullerton, United States· Recruiting
  • Providence Saint Johns Health Center
    Santa Monica, United States· Recruiting
  • Rocky Mountain Cancer Centers
    Denver, United States· Recruiting
  • Medical Oncology Hematology Consultants Helen F Graham Cancer Center
    Newark, United States· Recruiting
  • City of Hope Atlanta
    Newnan, United States· Recruiting
  • University of Illinois Chicago
    Chicago, United States· Recruiting
  • Midwestern Regional Medical Center dba City of Hope Chicago
    Zion, United States· Recruiting
  • University of Kansas Medical Center
    Westwood, United States· Recruiting
  • University of Louisville Health - James Graham Brown Cancer Center
    Louisville, United States· Recruiting

+121 more sites — see the official record for the full list.

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This is prostate cancer that has spread beyond the prostate (metastatic) and is still growing even though your body's testosterone levels are very low (castration-resistant).

What is Xaluritamig?

Xaluritamig is a new investigational drug being tested in this study. Its exact action will be explained by the study team.

Will I definitely get the new treatment?

No, this is a 'comparison' study. You will receive either the new treatment combination or one of the standard treatments, depending on what the study assigns you to.

What if my cancer gets worse during the study?

The study team will closely monitor your health. If your cancer worsens or you experience serious side effects, they will discuss your options with you, which may include stopping the study treatment.

How long will I be in the study?

The length of your participation will depend on how you respond to treatment and the study's plan. The study team will provide more specific details.

How to find out more

Amgen Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Xaluritamig Plus Abiraterone Versus Investigator'…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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