A Phase 3 Study of Xaluritamig Plus Abiraterone vs Investigator's Choice in chemotherapy naive mCRPC
Research type
Research Study
Full title
A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator’s Choice in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
IRAS ID
1012414
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2025-520555-89
Research summary
This is a phase 3 study, the late stage of the development process of new medicines. Researchers will compare study products to standard treatments in participants with metastatic castration-resistant prostate cancer (mCRPC) who have not been treated previously with chemotherapy. Participants will be randomly assigned into one of two different groups to receive either study products or standard treatments chosen by the study doctor.
The study may last for about 7 years for each participant, including a screening period of up to 28 days. Participants will be treated until worsening of disease, unacceptable side effects, death, withdrawal of informed consent or end of study as determined by the sponsor, whichever occurs first.
The study will include men, who are at least 18 years old and have mCRPC that has worsened after receiving treatment with other cancer drugs. Participants must have a tissue sample confirming the diagnosis of prostate cancer, good organ function and be healthy enough to receive the study treatments. Participants who have a history of cancer that has spread to the brain or spinal cord, have unresolved side effects from previous cancer treatments, have received prior treatment with progression on abiraterone or have received prior treatment with chemotherapy for mCRPC will not be included in this study.REC name
Wales REC 5
REC reference
25/WA/0207
Date of REC Opinion
6 Aug 2025
REC opinion
Further Information Favourable Opinion