Targeted radiation zaps prostate cancer cells in new trial

NCT ID NCT06549465

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This phase 2 study tests a radioactive antibody, Ac-225 rosopatamab tetraxetan, that seeks out and delivers radiation directly to prostate cancer cells. It is for men with a specific type of advanced prostate cancer that has stopped responding to hormone therapy. The trial aims to find the best dose and evaluate how well the treatment shrinks tumors or lowers PSA levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radioactive antibody called Ac-225 rosopatamab tetraxetan that targets prostate cancer cells
What this could lead to
If successful, this could provide a more effective treatment option for men with advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the treatment may not prove effective or may cause significant side effects from radiation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 93 people

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

Started

Aug 2024

Expected to finish

Apr 2027

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: * Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: 1. Serum PSA progression as defined by PCWG3 (rising PSA consisting of two consecutive increases measured at least 3 weeks apart, of a rise of \>25%, and with an absolute rise of 2.0 ng/mL. 2. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by CT/magnetic resonance imaging (MRI) 3. Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan 4. Identification of new soft tissue or bone lesions on PSMA PET imaging * Metastatic disease defined as either or both of the following: 1. Parts 1, 2, 3, and 4: Documented M1 disease on conventional imaging (CT/MRI of the chest/abdomen/pelvis and/or Technetium 99m \[99mTc\] whole-body bone scan) 2. Parts 1, 2, and 4 only: Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent * PSMA PET-positive disease, defined as at least one PSMA-positive metastatic lesion and no PSMA-negative lesions * Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate) * The standard of care use (in the setting of metastatic CRPC with significant burden of active bone metastases) of antiresorptive bone-targeted agents (e.g., zoledronic acid, denosumab) is required for all participants without a contraindication, for at least 4 weeks prior to administration of Ac-225 rosopatamab tetraxetan. * Participants with HIV are eligible if they are well-controlled (i.e, an undetectable HIV viral load (\<50 copies/mL) within 6 months of enrollment and a stable ART regimen for at least 6 months prior to enrollment) and at low risk for HIV-related illness Part 3 Only: * Prior treatment with Lu-177-PSMA-radioligand therapy * Prior treatment with up to only one taxane-based chemotherapy regimen is allowed Exclusion Criteria: * Superscans by nuclear medicine/99mTc bone scan * A known malignancy that is progressing or has required active treatment within the past 3 years other than CRPC, which is expected to alter life expectancy or may interfere with CRPC disease assessment * Prior platinum-based chemotherapy * Prior PARP inhibitors (e.g., olaparib or rucaparib) * Prior treatment with Radium-223, Actinium-225, Strontium-89, Samarium-153, Rheunium-186, or Rhenium-188 * Participants receiving anti-coagulants or anti-platelet drugs (e.g., aspirin or nonsteroidal anti-inflammatory drugs \[NSAIDs\]) who cannot discontinue use if platelet count decreases to \<50,000 Part 2 and 4 Only: * Prior chemotherapy for CRPC. Prior taxane chemotherapy for HSPC is allowed if discontinued ≥1 year prior to randomization * Prior radiopharmaceutical therapy (e.g., Ra-223, Lu-177-PSMA-617, or Lu-177-PSMA-I\&T) * Prior PSMA-targeted therapy, except for bispecific or CAR-T therapies Part 3 Only: * Prior PSMA-targeted therapy (e.g., antibody-drug conjugates or CAR-T therapy), except for Lu-177-PSMA-radioligand therapy and bispecific or CAR-T therapies

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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 places running it

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

  2. 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 ↗

  3. 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

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Laura & Isaac Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • New York Presbyterian/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • University of California San Diego

    RECRUITING

    San Diego, California, 92093, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63130, United States

  • X Cancer Omaha / Urology Cancer Center

    RECRUITING

    Omaha, Nebraska, 68130-5606, United States

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