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