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
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.
- 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
Locations (133)
- City of Hope Cancer Center PhoenixGoodyear, United States· Recruiting
- City of Hope National Medical CenterDuarte, United States· Recruiting
- City of Hope Orange County Lennar Foundation Cancer CenterDuarte, United States· Recruiting
- Providence Saint Jude Medical CenterFullerton, United States· Recruiting
- Providence Saint Johns Health CenterSanta Monica, United States· Recruiting
- Rocky Mountain Cancer CentersDenver, United States· Recruiting
- Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewark, United States· Recruiting
- City of Hope AtlantaNewnan, United States· Recruiting
- University of Illinois ChicagoChicago, United States· Recruiting
- Midwestern Regional Medical Center dba City of Hope ChicagoZion, United States· Recruiting
- University of Kansas Medical CenterWestwood, United States· Recruiting
- University of Louisville Health - James Graham Brown Cancer CenterLouisville, 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?
Discussion
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