Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

This study, named XALute, is for men with advanced prostate cancer that continues to grow despite standard hormone treatment (metastatic castration-resistant prostate cancer). It is testing a new drug, Xaluritamig, against current commonly used treatments such as Cabazitaxel or other hormone-based medicines (like Abiraterone or Enzalutamide). The main goal is to see if Xaluritamig can help men live longer compared to these existing options. Participants will be carefully monitored throughout the study. This research aims to find better ways to manage this type of prostate cancer and improve patients' lives. Researchers will compare how well Xaluritamig works against the doctor's choice of standard treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

707

Start

09 Dec 2024

Estimated completion

30 Jul 2029

Metastatic Castration-resistant Prostate Cancer

What is this study about?

This clinical trial is investigating a new treatment called Xaluritamig for men diagnosed with advanced prostate cancer. This specific type of cancer is called 'metastatic castration-resistant prostate cancer,' which means the cancer has spread to other parts of the body (metastatic) and is still growing even after hormone treatment to lower testosterone (castration-resistant).

The main purpose of this study is to compare Xaluritamig with treatments that doctors already use, such as Cabazitaxel or a second type of hormone therapy (like Abiraterone or Enzalutamide). The researchers want to find out if Xaluritamig is better at helping men live longer than these standard options. By conducting this research, doctors hope to discover more effective ways to treat this challenging form of prostate cancer.

Participation in this study could offer access to a new experimental treatment. However, it's important to remember that this is a research study, and we don't yet know if Xaluritamig will be more effective or safer than current treatments. All participants will be closely monitored by a medical team throughout the trial to ensure their safety and track their progress.

Key takeaways

Tests a new medicine, Xaluritamig, for advanced prostate cancer.
Compares Xaluritamig to existing standard treatments.
Aims to see if Xaluritamig helps men live longer.
For men whose prostate cancer has spread and is resistant to hormone treatment.
Requires previous treatment with at least one hormone therapy and one chemotherapy.

Who may be eligible?

This study is looking for men aged 18 or older who have advanced prostate cancer that has spread and is no longer responding to initial hormone treatments. Your doctor must have confirmed your prostate cancer as adenocarcinoma, and it cannot be mixed with other types of cancer.

You must have signs of the cancer getting worse, which could be seen in your blood tests (like PSA levels), scans (like CT, MRI, or bone scans showing new or growing spots), or both. You must have already had surgery to remove your testicles or be receiving ongoing hormone therapy to keep your testosterone levels very low. You also need to have tried at least one hormone-blocking medicine before (like enzalutamide or abiraterone) and had one type of chemotherapy (taxane medicine) for your advanced prostate cancer.

Your general health and ability to perform daily activities need to be good, as assessed by a doctor. Specific types of earlier treatments might affect whether you can join, so your medical history will be carefully reviewed.

Quick self-check

Are you 18 years old or older?
Do you have advanced prostate cancer that has spread and kept growing despite hormone treatment?
Have you already had at least one hormone-blocking medicine and one chemotherapy for your advanced prostate cancer?
Is your general health good enough for you to manage daily activities?
Do your scans and blood tests show that your cancer is currently getting worse?

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

What does participation involve?

If you decide to take part, you will be assigned to receive either the new medicine, Xaluritamig, or one of the standard treatments (Cabazitaxel or another hormone-based medicine chosen by your doctor). You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These tests will help the doctors keep track of your cancer and any side effects you might experience.

The specific schedule for visits and tests will depend on the treatment you receive, but you can expect frequent monitoring throughout the study. The total duration of your participation will vary depending on how you respond to the treatment and the study's requirements. You will receive the study medication as directed by the research team. After treatment, there will likely be follow-up appointments to continue monitoring your long-term health and the effects of the treatment.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment that might be more effective than current options, though this is not guaranteed. All medicines can have side effects, and Xaluritamig is still being investigated, so its full range of risks isn't fully known yet. You will be closely monitored for any side effects, and the medical team will provide care and support. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (164)

University of Alabama at Birmingham
Birmingham, United States
City of Hope National Medical Center
Duarte, United States
Providence Saint Jude Medical Center
Fullerton, United States
Cedars Sinai Medical Center
Los Angeles, United States
University of California Irvine
Orange, United States
University of California San Francisco
San Francisco, United States
University of Florida, College of Medicine
Gainesville, United States
Sylvester Comprehensive Cancer Center-Fox Building
Miami, United States
AdventHealth Orlando
Orlando, United States
University of Chicago
Chicago, United States
Indiana University
Indianapolis, United States
University of Louisville Health - James Graham Brown Cancer Center
Louisville, United States

+152 more sites — see the official record for the full list.

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body (metastatic) and is still growing even though you're receiving hormone treatment to lower your testosterone (castration-resistant).

What is Xaluritamig?

Xaluritamig is a new experimental drug being tested in this study. We are trying to find out if it is a better treatment option for this type of prostate cancer.

What kinds of treatments will Xaluritamig be compared to?

It will be compared to existing treatments like Cabazitaxel (a chemotherapy) or a second type of hormone therapy such as Abiraterone or Enzalutamide.

Will I know which treatment I am getting?

Yes, in this study, you will know if you are receiving Xaluritamig or one of the standard treatments chosen by your doctor.

What is the main goal of the study?

The main goal is to see if Xaluritamig helps men with this type of prostate cancer live longer compared to men receiving the standard treatments.