Clinical Trials of PSMA RPT
| Trial | Year | Subjects (n) | Location | Description | Diagnostic agent | Therapeutic agent | Clinical phase | Outcome | Comments |
|---|---|---|---|---|---|---|---|---|---|
| LuPSMA (7) | 2018 | 30 | Australia | Prospective phase 2, single-center, single-arm trial | 68Ga, no 18F-FDG+ | 177Lu | mCRPC | PSA50 achieved by 57% | Grade 1 xerostomia in 87% and grade 3–4 thrombocytopenia in 13% |
| TheraP (8), NCT03392428 | 2021 | 35 | Australia | Randomized phase 2 trial | 68Ga, no 18F-FDG+ | 177Lu | mCRPC | 177Lu-PSMA more effective than cabazitaxel | RPT with less grade 3–4 toxicity (33%) than cabazitaxel (53%); RPT with 61% grade 1–2 xerostomia |
| VISION (9), NCT03511664 | 2022 | 831 | International | Open-label, 2:1 randomized, phase 3 trial of 177Lu-PSMA + SOC vs. SOC; previously treated with at least 1 ARPI and taxane | 68Ga | 177Lu | mCRPC | PFS (median, 8.7 vs. 3.4 mo); OS (median, 15.3 vs. 11.3 mo) | Adverse events of grade ≥ 3 higher with 177Lu-PSMA than without (52.7% vs. 38.0%) |
| EnzaP (20), NCT04419402 | 2020 | 160 | Australia | Open-label, 1:1 randomized, phase 2 trial of ENZ alone or ENZ + 177Lu-PSMA | 68Ga | 177Lu | mCRPC | PSA PFS | Ongoing prospective trial |
| PSMAFore (21), NCT04689828 | 2022 | Estimation: 450 | International | Open-label, phase 3, multicenter trial | 68Ga | 177Lu | mCRPC | rPFS | Ongoing prospective trial |
| PSMAddition (22), NCT04720157 | 2022 | Estimation: 1,126 | International | Open-label, phase 3, 1:1 randomized trial of RPT + SOC vs. SOC | 68Ga | 177Lu | mCSPC | rPFS | Ongoing prospective trial |
| UPFrontPSMA (23), NCT04343885 | 2021 | Estimation: 140 | Australia | Open-label, multicenter, phase 2, 1:1 randomized trial of RPT + DTX vs. DTX | 68Ga | 177Lu | mCSPC | Undetectable PSA at 1 y | Ongoing prospective trial |
| SPLASH (24), NCT04647526 | 2021 | Estimation: 260 | International | Open-label, multicenter, phase 3 trial | 68Ga or 18F | 177Lu | mCRPC | rPFS | Ongoing prospective trial |
| ECLIPSE (25), NCT05204927 | 2022 | Estimation: 400 | United States | Open-label, multicenter, phase 3 trial | 68Ga or 18F | 177Lu | mCRPC | rPFS | Ongoing prospective trial |
| LuTectomy (26), NCT04430192 | 2021 | 20 | Australia | Open-label, phase 1/2, nonrandomized trial of dosimetry, efficacy, safety of 177Lu-PSMA | 68Ga | 177Lu | High-risk prostate cancer | Absorbed radiation dose of prostate and metastatic lymph nodes | Ongoing prospective trial |
| PRINCE (27), NCT03658447 | 2022 | 37 | Australia | Phase 1/2, safety and efficacy trial of RPT and programmed death 1 inhibitor | 68Ga | 177Lu | mCRPC | PSA50 | Ongoing prospective trial |
| LuPARP (28), NCT03874884 | 2022 | 52 | Australia | Phase 1 dose-escalation and dose-expansion trial | 68Ga | 177Lu | mCRPC | Primary outcomes: DLT, MTD, and RP2D | Ongoing prospective trial |
| TATCIST (29), NCT05219500 | 2022 | Estimation: 100 | Texas | 225Ac-PSMA I&T | 68Ga | 225Ac | mCRPC | PSA50 | Ongoing prospective trial |
177Lu-PSMA = 177Lu-PSMA-617; ARPI = androgen receptor pathway inhibitor; PFS = progression-free survival; ENZ = enzalutamide; DTX = docetaxel; DLT = dose-limiting toxicity; MTD = maximum tolerated dose; RP2D = recommended phase 2 dose.