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New drug combo aims to shrink prostate tumors before surgery

NCT ID NCT06613100

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109-1023, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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