Second dose of targeted radiation shows promise for tough prostate cancer
NCT ID NCT06288113
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a second round of a radioactive drug called 177Lu-PSMA-617 can help men with advanced prostate cancer that no longer responds to hormone therapy. The drug targets and delivers radiation directly to cancer cells. Participants must have already had a good response to their first round of this treatment. The goal is to see if re-treatment can improve survival and control the disease longer.
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 40 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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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Patients must have mCRPC * Patients must have received at least one regimen of chemotherapy for mCRPC * Patients must have received at least one androgen receptor signaling inhibitor (ARSI) * Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy * Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as: * PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND * No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \[ADT\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart * Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy * White blood cells \> 2,500 cells/µL * Absolute neutrophil count \> 1,500 cells/µL * Hemoglobin \> 9.0 g/dL * Platelets \> 100,000 cells/µL * Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements Exclusion Criteria: * Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed * Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks * Patient with creatinine clearance \< 50 mL/min
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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
1 site. 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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UCLA / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered immune cells take down advanced prostate cancer?
- Can a Chemo-Targeted drug combo outsmart Treatment-Resistant prostate cancer?
- Can a tracer that hunts unstable iron light up hidden tumors?
- Can a three-drug cocktail outsmart resistant prostate cancer?
- Precision radiation may tame rising PSA after prostate surgery
- Blood test could tell doctors when to stop prostate cancer treatment early