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

Required: FOLH1 PSMA PET/CT VISION criteria

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

Must have received: chemotherapy — for mCRPC

Patients must have received at least one regimen of chemotherapy for mCRPC

Must have received: androgen receptor signaling inhibitor

Patients must have received at least one androgen receptor signaling inhibitor (ARSI)

Must have received: 177Lu-PSMA-617 (177Lu-PSMA-617)

Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy

Cannot have received: myelosuppressive therapy (docetaxel, cabazitaxel, 223Ra, 153Sm)

Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks

Cannot have received: radionuclide therapy

Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks

Cannot have received: prostate cancer therapy (apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, biological therapy)

Exception: first-generation ADT is allowed; concomitant therapy during and continued after first regimen of 177Lu-PSMA-617 is allowed

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