RecruitingPhase 2NCT06288113

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

Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with metastatic prostate cancer that has become resistant to hormone therapy (mCRPC) can safely and effectively receive a second course of lutetium-177 PSMA therapy (Lu-PSMA) after they had a good initial response and later progressed. **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (cancer that has spread and no longer responds to hormone therapy) - You have previously completed at least 4 cycles of Lu-PSMA-617 therapy with a good response (PSA dropped by 50% or more) - You have since received at least one chemotherapy regimen and at least one hormone-blocking drug for your mCRPC **You may NOT be eligible if...** - You did not have a good initial response to your first course of Lu-PSMA - You started new cancer therapy within 2 months of finishing your first Lu-PSMA regimen - You have significant kidney, liver, or bone marrow problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo PET/CT and SPECT/CT

OTHERGallium Ga 68 Gozetotide

Given IV

DRUGLutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT06288113


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