Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)
Jonsson Comprehensive Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy (for a maximum of 6 additional cycles) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had a favorable response to a prior regimen of 177Lu-PSMA-617 therapy. SECONDARY OBJECTIVES: I. To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. II. To determine the rate of patients who have a prostate-specific antigen (PSA) response (defined as a PSA decline…
Eligibility
- Age range
- Not specified
- Sex
- Male
- Healthy volunteers
- No
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…
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
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California