Targeted radiation zaps prostate cancer cells in new trial
NCT ID NCT06549465
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Apr 2027
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: * 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.
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The places running it
9 sites. 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
Locations
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Laura & Isaac Perlmutter Cancer Center
RECRUITINGNew York, New York, 10016, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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New York Presbyterian/Weill Cornell Medical Center
RECRUITINGNew York, New York, 10065, United States
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The Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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University of California San Diego
RECRUITINGSan Diego, California, 92093, United States
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Washington University in St. Louis
RECRUITINGSt Louis, Missouri, 63130, United States
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X Cancer Omaha / Urology Cancer Center
RECRUITINGOmaha, Nebraska, 68130-5606, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?
- Can a radioactive injection extend life in advanced prostate cancer?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?
- Can a new pill outsmart resistant prostate cancer?