Could treatment holidays improve prostate cancer therapy?
NCT ID NCT06216249
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with advanced prostate cancer that has spread and stopped responding to standard treatments. It compares the usual fixed schedule of 6 doses of Lu-PSMA therapy to a flexible schedule that allows up to 12 doses with breaks (treatment holidays) based on how well the cancer responds. The goal is to see if the flexible approach improves survival and reduces side effects.
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 90 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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Dec 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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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.
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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 prostate cancer proven by histopathology * Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging \[MRI\], bone scan, PET) * Patients must have received at least one regimen of chemotherapy for mCRPC * Patients must have received at least one androgen-receptor signaling inhibitors (ARSI) * Patients must be eligible by PSMA PET VISION criteria. PSMA PET/CT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617 * White blood cell (WBC) ≥ 2,500/ul * Platelets (PLT) ≥ 100,000/ul * Hemoglobin (Hb) ≥ 9.0 g/dl * Absolute neutrophil count (ANC) ≥ 1,500 ul * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Patients must be adults ≥ 18 years of age * Patients must have the ability to understand and sign an approved informed consent form (ICF) * Patients must have the ability to understand and comply with all protocol requirements Exclusion Criteria: * Prior cycle of 177Lu-PSMA-617 therapy * Less than 6 weeks between last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation) and first cycle of 177Lu-PSMA-617 therapy * Glomerular filtration rate (GFR) \< 50 ml/min * Urinary tract obstruction or marked hydronephrosis
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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
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Other studies related to the condition(s) this trial covers.
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