Official Title: A Phase III, 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
A Study On:
Prostate
Study Description
The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy [ARDT]).
Eligibility
INCLUSION CRITERIA:
Participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
Participants must have had prior treatment with at least one androgen receptor-directed therapy.
Participants must demonstrate adequate organ function.
EXCLUSION CRITERIA:
Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen suppression therapy, is not permitted.
Radiation therapy within 4 weeks prior to the first dose of study treatment (or local or focal radiotherapy within 2 weeks prior to the first dose of study treatment) is not permitted.
Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly ADP-ribose polymerase inhibitor, biological therapy, or investigational therapy is not permitted.
Participants with a history of central nervous system (CNS) metastasis are not permitted.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.
Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.
You are being asked to participate in a clinical research potential participant database to identify
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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
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Data Retention - In accordance with UC Office of the President policy, information will be retained for
10 years after the end of the calendar year in which the research is completed.
If, during the course of this study, significant new information becomes available that may relate to
your willingness to continue to participate, this information will be provided to you by the research
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contact the researchers listed at the top of this form
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The IRB’s role is to protect the rights and welfare of human subjects involved in
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institutional policies.
