Phase 3 Study Comparing Xaluritamig with Cabazitaxel or Other Hormone Therapy in Patients with Advanced Prostate Cancer
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT06691984
This clinical trial is comparing the effectiveness of a new drug, Xaluritamig, against standard treatments like Cabazitaxel or other hormone therapies in patients with advanced prostate cancer that has continued to progress despite previous treatments.
Patient Parameters
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Program Overview
The main goal of this study is to see if Xaluritamig can help patients with advanced prostate cancer live longer compared to those receiving standard treatments like Cabazitaxel or other hormone therapies. The study focuses on patients whose cancer has spread and is not responding to traditional hormone treatments.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent before starting any study-related activities.
- Must be 18 years or older.
- Must have a confirmed diagnosis of prostate cancer.
- Must have advanced prostate cancer with at least one tumor that can be seen on a scan.
- Must show signs of cancer progression, such as rising PSA levels or new tumors.
- Must have had surgery to remove the testicles or be on hormone therapy to lower testosterone levels.
- Must have previously been treated with at least one hormone therapy and one chemotherapy drug.
- Must have good overall health with an ECOG performance status of 0 or 1.
- Must have adequate organ function.
Exclusion Criteria
- Cannot have received certain prostate-targeted therapies before.
- Cannot have had any cancer treatments or experimental drugs within 4 weeks before starting the study, except for hormone therapy.
- Cannot have had certain prostate-specific treatments within 2 months before starting the study.
- Cannot have started certain bone-strengthening treatments within 4 weeks before starting the study.
- Cannot have had radiation therapy within 4 weeks before starting the study.
- Cannot have active brain metastases.
- Cannot have unresolved side effects from previous cancer treatments, except for hair loss or stable, well-controlled side effects.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| University of California Irvine | 92697 | Irvine | California |
| AdventHealth Orlando | 32804 | Orlando | Florida |
| Thomas Jefferson University Hospital | 19107 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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