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RE-LuPSMA Trial: Re-treatment with 177Lu-PSMA-617 for Metastatic Prostate Cancer

This study is looking at how well re-treatment with 177Lu-PSMA-617 works for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and continues to grow despite hormone therapy. You may be able to join if you've already had chemotherapy, another type of hormone therapy (ARSI), and at least 4 cycles of 177Lu-PSMA-617, and had a good response to that first treatment. 177Lu-PSMA-617 is a radioactive drug that targets and delivers radiation to prostate cancer cells. The main goal is to see how long patients live after re-treatment. The study is currently recruiting 40 men.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 men.
What's involved
You would undergo blood sample collections, PET/CT and SPECT/CT scans, and receive intravenous (IV) doses of Gallium Ga 68 Gozetotide and Lutetium Lu 177 Vipivotide Tetraxetan. The re-treatment with 177Lu-PSMA-617 can be for a maximum of 6 additional cycles.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be assessed at 12 months after the start of re-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06288113

Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

Recruiting
PHASE2All AgesInterventionalTreatment
Jonsson Comprehensive Cancer Center
~40 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyGallium Ga 68 GozetotideLutetium Lu 177 Vipivotide TetraxetanPositron Emission TomographyQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
12-month overall survival
Measured over Assessed at 12 months

Conditions

Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeremie Calais, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Stephanie Lira
[email protected]
3102060596
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 12-month overall survivalAssessed at 12 months

    12-month overall survival (OS) of patients with mCRPC who previously had a favorable response to a first regimen of 177Lu-PSMA-617 and are treated with re-challenge 177Lu-PSMA-617 therapy