A research study for men with advanced prostate cancer.

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

Patient Summary

What is a research study?

Before a new cancer treatment is approved for patients, it must go through testing to make sure it is both safe and effective. The process of testing a treatment in people is called clinical research. Clinical research is done very carefully, with strict oversight and adherence to ethical guidelines. The well-being of study participants is the number one priority.

Why is this study being done?

This study is being done to learn more about an investigational study medicine for prostate cancer. The study is for men whose prostate cancer has spread to other parts of the body (metastatic castration-resistant prostate cancer) and who have already been treated with chemotherapy.

What is the investigational study medicine?

The investigational study medicine is in a different class of drugs than standard treatments. It is designed to help the immune system target and attack prostate cancer. You’ll get either the investigational study medicine or a current standard treatment chosen by your doctor. Standard treatment options include chemotherapy (cabazitaxel) or an androgen receptor pathway inhibitor (abiraterone or enzalutamide).

• You have a 2 in 3 chance of receiving the investigational study medicine.
• You have a 1 in 3 chance of receiving a standard treatment.

Who can join the study?

You may be able to join the study if you:

• Have prostate cancer that has spread and no longer responds to hormone therapy.
• Have been treated with chemotherapy.

There are other requirements. The study doctor will talk with you and check to see if this study is right for you.

Study-related treatment, imaging scans, and doctor visits will be provided at no cost to you. The study clinic may provide additional help, such as paying you back for travel expenses.

What happens during the study?

Your participation in the study may last up to 56 months. This includes time for the initial evaluation, study treatment, and about 36 months of follow-up. During the study, you’ll visit the study doctor regularly and have scheduled imaging scans. (Includes physical exams, heart tests, blood test, questionnaires, CT/MRI Scan*, and Bone Scan*.

*Every 8 weeks for 48 weeks, then every 12 weeks
CT = computed tomography
MRI – magnetic resonance imaging

 How long you are treated will depend on how well your cancer responds and how well your body handles any side effects.

What should I do next?

If you are interested in learning more and possibly joining the study,

• Speak to the study staff. We will explain the study and answer your questions. We will also give you written materials to read at your own pace.
• Talk to the people you trust to help you understand and make medical decisions. We welcome them to be part of the process and ask questions.
• Read and sign the Informed Consent Form.  Being in a study is 100% voluntary and you can leave at any time for any reason.
• Visit the Amgen Pre-Screener to see if you qualify. 

Organization: 

Amgen: XALutestudy.com

ClinicalTrials.gov Information:

• NCT Number: NCT06691984 (also listed as 20230005; targeted enrollment ≈675)
• Title: Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.

Register your interest or comments about this trial with PHEN

Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.