Actively Recruiting
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
Led by Amgen · Updated on 2026-05-14
40
Participants Needed
9
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by radical prostatectomy, and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered as monotherapy or in combination with an oral GnRH antagonist in the neoadjuvant setting.
CONDITIONS
Official Title
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned radical prostatectomy surgery
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine, signet cell, or small cell features
- Intermediate- or high-risk localized prostate cancer defined by Gleason score 4+3 or higher and initial PSA over 10, or clinically advanced cT3 on MRI within 3 months before screening, or positive locoregional lymph nodes detected by PSMA-PET or MRI (5 or fewer local lymph nodes)
- Underwent PSMA-PET (CT or MRI) scan within 3 months before screening as part of standard care
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Prior treatment for prostate cancer (except participants in cohort B who may have received oral GnRH antagonist up to 3 months before screening)
- Evidence of metastases outside surgical resection field by conventional imaging or PSMA-PET scans
- Confirmed history or current autoimmune disease or other diseases causing permanent immunosuppression or requiring permanent immunosuppressive therapy
- Symptoms, clinical signs, or radiographic signs of acute or uncontrolled active systemic infection within 7 days before first dose of study treatment
- Active infection requiring antibiotics (participant may become eligible after completing antibiotics and symptom resolution)
- Recent arterial or venous thrombosis: stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis within 6 or 3 months respectively before first dose of study treatment (stable anticoagulation required for venous thrombosis history)
- Myocardial infarction or symptomatic congestive heart failure (NYHA class II or higher) within 12 months before first dose of xaluritamig, except controlled ischemia or non-ST segment elevation myocardial infarction with stent placement over 6 months before first dose
- Need for chronic systemic corticosteroid therapy unless stopped with proper tapering at least 7 days before dosing
- Currently receiving treatment in another investigational drug or device study or less than 4 weeks since ending such treatment (except investigational scans and observational research studies are allowed)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
6
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109-1023
Actively Recruiting
7
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
8
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
9
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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