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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.
