New drug combo aims to shrink prostate tumors before surgery
NCT ID NCT06613100
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-stage trial is testing a drug called xaluritamig, given alone or with a hormone blocker, before men with intermediate- or high-risk prostate cancer have their prostate removed. The main goal is to see if the treatment is safe and does not interfere with surgery. About 40 men will take part, and researchers will also look at how the drug affects PSA levels and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- xaluritamig (a drug given by IV) and a GnRH antagonist (oral hormone blocker)
- What this could lead to
- If it works, this could point toward a way to shrink prostate tumors before surgery, potentially improving outcomes for men with aggressive prostate cancer.
- What could go wrong
- This is a very early (Phase 1) study with only 40 participants, so it is mainly checking safety and feasibility—not yet testing if it truly works. Side effects from the drugs or surgery complications are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participants planned to undergo radical prostatectomy. * Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as: * Gleason score of 4+3 or higher AND initial PSA (iPSA) \>10 OR * Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3 months prior to screening AND/OR * Positive locoregional lymph nodes as detected by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes on MRI can be enrolled. * Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior to screening as part of the standard of care (SOC). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Prior treatment for participant's prostate cancer. \- Exception: Participants intended for enrollment in cohort B may have received an oral GnRH antagonist up to 3 months prior to the start of screening. * Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans. * Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. * Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment: \- Participant has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint. * Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to the first dose of study treatment, respectively. Note: Participants with a history of venous thrombosis must be on stable anti-coagulation. * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig. * Requirement for chronic systemic corticosteroid therapy unless stopped (with adequate tapering) within 7 days prior to dosing. * Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study\[ies\]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Carolina Urologic Research Center
RECRUITINGMyrtle Beach, South Carolina, 29572, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109-1023, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Universitaetsklinikum Essen
RECRUITINGEssen, 45147, Germany
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Universitaetsklinikum Hamburg Eppendorf
RECRUITINGHamburg, 20246, Germany
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University of California San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?