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Research ArticleContinuing Education

Clinical Trials of Prostate-Specific Membrane Antigen Radiopharmaceutical Therapy

Hossein Jadvar and Patrick M. Colletti
Journal of Nuclear Medicine Technology March 2023, 51 (1) 16-21; DOI: https://doi.org/10.2967/jnmt.122.264928
Hossein Jadvar
Division of Nuclear Medicine, Department of Radiology, Keck School of Medicine, University of Southern California, Los Angeles, California
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Patrick M. Colletti
Division of Nuclear Medicine, Department of Radiology, Keck School of Medicine, University of Southern California, Los Angeles, California
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    TABLE 1.

    Clinical Trials of PSMA RPT

    TrialYearSubjects (n)LocationDescriptionDiagnostic agentTherapeutic agentClinical phaseOutcomeComments
    LuPSMA (7)201830AustraliaProspective phase 2, single-center, single-arm trial68Ga, no 18F-FDG+177LumCRPCPSA50 achieved by 57%Grade 1 xerostomia in 87% and grade 3–4 thrombocytopenia in 13%
    TheraP (8), NCT03392428202135AustraliaRandomized phase 2 trial68Ga, no 18F-FDG+177LumCRPC177Lu-PSMA more effective than cabazitaxelRPT with less grade 3–4 toxicity (33%) than cabazitaxel (53%); RPT with 61% grade 1–2 xerostomia
    VISION (9), NCT035116642022831InternationalOpen-label, 2:1 randomized, phase 3 trial of 177Lu-PSMA + SOC vs. SOC; previously treated with at least 1 ARPI and taxane68Ga177LumCRPCPFS (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), NCT044194022020160AustraliaOpen-label, 1:1 randomized, phase 2 trial of ENZ alone or ENZ + 177Lu-PSMA68Ga177LumCRPCPSA PFSOngoing prospective trial
    PSMAFore (21), NCT046898282022Estimation: 450InternationalOpen-label, phase 3, multicenter trial68Ga177LumCRPCrPFSOngoing prospective trial
    PSMAddition (22), NCT047201572022Estimation: 1,126InternationalOpen-label, phase 3, 1:1 randomized trial of RPT + SOC vs. SOC68Ga177LumCSPCrPFSOngoing prospective trial
    UPFrontPSMA (23), NCT043438852021Estimation: 140AustraliaOpen-label, multicenter, phase 2, 1:1 randomized trial of RPT + DTX vs. DTX68Ga177LumCSPCUndetectable PSA at 1 yOngoing prospective trial
    SPLASH (24), NCT046475262021Estimation: 260InternationalOpen-label, multicenter, phase 3 trial68Ga or 18F177LumCRPCrPFSOngoing prospective trial
    ECLIPSE (25), NCT052049272022Estimation: 400United StatesOpen-label, multicenter, phase 3 trial68Ga or 18F177LumCRPCrPFSOngoing prospective trial
    LuTectomy (26), NCT04430192202120AustraliaOpen-label, phase 1/2, nonrandomized trial of dosimetry, efficacy, safety of 177Lu-PSMA68Ga177LuHigh-risk prostate cancerAbsorbed radiation dose of prostate and metastatic lymph nodesOngoing prospective trial
    PRINCE (27), NCT03658447202237AustraliaPhase 1/2, safety and efficacy trial of RPT and programmed death 1 inhibitor68Ga177LumCRPCPSA50Ongoing prospective trial
    LuPARP (28), NCT03874884202252AustraliaPhase 1 dose-escalation and dose-expansion trial68Ga177LumCRPCPrimary outcomes: DLT, MTD, and RP2DOngoing prospective trial
    TATCIST (29), NCT052195002022Estimation: 100Texas225Ac-PSMA I&T68Ga225AcmCRPCPSA50Ongoing 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.

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Journal of Nuclear Medicine Technology: 51 (1)
Journal of Nuclear Medicine Technology
Vol. 51, Issue 1
March 1, 2023
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Clinical Trials of Prostate-Specific Membrane Antigen Radiopharmaceutical Therapy
Hossein Jadvar, Patrick M. Colletti
Journal of Nuclear Medicine Technology Mar 2023, 51 (1) 16-21; DOI: 10.2967/jnmt.122.264928

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Clinical Trials of Prostate-Specific Membrane Antigen Radiopharmaceutical Therapy
Hossein Jadvar, Patrick M. Colletti
Journal of Nuclear Medicine Technology Mar 2023, 51 (1) 16-21; DOI: 10.2967/jnmt.122.264928
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    • Abstract
    • LUPSMA
    • THERAP
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    • UPFRONTPSMA
    • SPLASH
    • ECLIPSE
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Keywords

  • prostate
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  • VISION
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