Table 2.
Ongoing clinical trials of PSMA RLT with enrolment of at least 50 participants.
| Radioligand | Clinical Trial Identifier | Study Title | Phase | Primary Study Objective |
|---|---|---|---|---|
| I-131-1095 | NCT03939689 | Radiotherapy in Combination With Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (ARROW) | II | Evaluate the safety and efficacy of I-131-1095 in combination with Enzalutamide in patients with PSMA-avid mCRPC. |
| 177Lu-PSMA-617 | NCT03874884 | 177Lu-PSMA-617 Therapy and Olaparib in Patients with Metastatic Castration Resistant Prostate Cancer (LuPARP) | I | Evaluate safety and tolerability of Olaparib and 177Lutetium-PSMA in patients with mCRPC. |
| NCT03545165 | 177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC | I | Determine the dose-limiting toxicity and maximum tolerated dose (MTD) of combined 177Lu-PSMA-J591 and 177Lu-PSMA-671 in patients with mCRPC. | |
| NCT03392428 | A Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer | II | Determine the activity and safety of 177Lu-PSMA vs. cabazitaxel in men with progressive mCRPC. | |
| NCT03454750 | Radiometabolic Therapy (RMT) with 177Lu-PSMA617 in Advanced Castration Resistant Prostate Cancer (CRPC) (LU-PSMA) | II | Evaluate efficacy and toxicity of radiometabolic therapy with 177LuPSMA-617 in advanced CRPC. | |
| NCT04343885 | In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy (UpFrontPSMA) | II | Compare the effectiveness of 177Lu-PSMA therapy followed by docetaxel chemotherapy vs. docetaxel chemotherapy alone in patients with newly-diagnosed high-volume metastatic hormone-naïve prostate cancer (mHNPC). | |
| NCT03392428 | A Trial of 177Lu-PSMA-617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer (TheraP) | II | Determine the activity and safety of 177Lu-PSMA vs. cabazitaxel in men with progressive mCRPC. | |
| NCT03511664 | Study of 177Lu-PSMA-617 in Metastatic Castrate-Resistant Prostate Cancer (VISION) | III | Compare OS in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone. | |
| 177Lu-PSMA-R2 | NCT03490838 | 177Lu-PSMA-R2 in Patients with PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer (PROter) | I/II | Assess safety, tolerability, radiation dosimetry, and preliminary efficacy of 177Lu-PSMA-R2 in patients with mCRPC. |
| 177Lu-PSMA-J591 | NCT00538668 | Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody | I | Determine the highest possible safe dose of 177Lu-PSMA-J591 and assess its effects on PCa. |
| NCT03545165 | 177Lu-J591 and 177Lu-PSMA-617 Combination of mCRPC | I/II | Determine dose-limiting toxicity and MTD of the combination of 177Lu-J591 and 177Lu-PSMA-617. | |
| AMG 160 | NCT03792841 | A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer | I | Evaluate the safety and tolerability of AMG 160, a half-life-extended (HLE) bispecific T-cell engager (BiTE®) antibody. |
| BAY 2315497 | NCT03724747 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients with Metastatic Castration Resistant Prostate Cancer | I | Define the safety and tolerability profile and MTD of BAY 2315497. |
| AMG 509 | NCT04221542 | Study of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer | I | Evaluate the safety, tolerability, and MTD of AMG 509 in adult subjects. |