Table 2.
Combination studies utilizing 177Lu-PSMA-617,
| Study name | Disease setting | NCT number | Clinical trial phase | Location | Primary outcome measure |
|---|---|---|---|---|---|
| EBRT + Lu-PSMA for N1M0 Prostate Cancer (PROQURE-1) | N1M0 | NCT05162573 | 1 | Netherlands | MTD |
| 177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer (LuPARP) | Metastatic castration-resistant Prostate Cancer | NCT03874884 | 1 | Australia | DLT MTD RP2D |
| 177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer | Metastatic castration-resistant prostate cancer | NCT03805594 | 1 | United States | RP2D ORR |
| Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (UPLIFT) | Metastatic castration-resistant prostate cancer | NCT05113537 | 1/2 | United States | DLT MTD RP2D Change in maximum standardized uptake value (SUVmax) |
| Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer (AlphaBet) | Metastatic castration-resistant prostate cancer | NCT05383079 | 1/2 | Australia | DLT MTD RP2D PSA response rate |
| Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer (LuCAB) | Metastatic castration-resistant prostate cancer | NCT05340374 | 1/2 | Australia | DLT MTD RP2D |
| PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr) (PRINCE) | Metastatic castration-resistant prostate cancer | NCT03658447 | 1/2 | Australia | PSA response rate Safety/Tolerability |
| Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer (ENZA-p) | Metastatic castration-resistant prostate cancer | NCT04419402 | 2 | Australia | PSA Progression-Free Survival |
| EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC (ANZUP2001) | Metastatic castration-resistant prostate cancer | NCT05150236 | 2 | Australia | PSA progression free survival |
| In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy (UpFrontPSMA) | Metastatic hormone naive prostate cancer | NCT04343885 | 2 | Australia | Undetectable PSA rate at 12 months |
Abbreviations: DLT, dose-limiting toxicity; MTD, maximum tolerated dose; ORR, objective response rate; RP2D, recommended phase II dose.