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177Lu-PSMA-I&T

DRUG5 trials

Sponsors

Curium Pet France, Weill Medical College of Cornell University, Curium US LLC, Peter MacCallum Cancer Centre, Australia, Instituto do Cancer do Estado de São Paulo

Conditions

Metastasis From Malignant Tumor of ProstateMetastatic Castrate Resistant Prostate Cancer (mCRPC)Prostate CancerProstate Cancer (Adenocarcinoma)metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1

Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
Active, not recruitingNCT04886986
Weill Medical College of Cornell UniversityProstate Cancer
Start: 2021-06-30End: 2029-12-01Updated: 2026-03-31
Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer
Not yet recruitingNCT07090369
Peter MacCallum Cancer Centre, AustraliaMetastatic Castrate Resistant Prostate Cancer (mCRPC)
Start: 2025-11-01End: 2028-12-01Target: 20Updated: 2025-07-29
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
Not yet recruitingNCT07316686
Instituto do Cancer do Estado de São PauloProstate Cancer (Adenocarcinoma)
Start: 2026-01-31End: 2026-12-31Target: 18Updated: 2026-01-05

Phase 3

177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
Active, not recruitingNCT05204927
Curium US LLCMetastasis From Malignant Tumor of Prostate
Start: 2022-02-14End: 2029-02-28Updated: 2025-07-31
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of [177Lu]LU-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer
Active, not recruitingCTIS2022-501493-19-00
Curium Pet Francemetastatic Castration-Resistant Prostate Cancer (mCRPC)
Start: 2023-02-20Target: 150Updated: 2025-10-28

Related Papers

PSMA-targeted actinium-225 therapy in metastatic castration-resistant prostate cancer (mCRPC): Baseline and follow-up PSMA PET parameters associated with outcomes.
Journal of Clinical Oncology2025-05-281 citations
Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer.
Journal of Clinical Oncology2025-02-10
Preclinical comparison of [177Lu]Lu-rhPSMA-10.1 and [177Lu]Lu-rhPSMA-10.2 for endoradiotherapy of prostate cancer: biodistribution and dosimetry studies
EJNMMI Radiopharmacy and Chemistry2024-02-2611 citations
Phase I dose-escalation results of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT) with alpha-radiolabeled antibody <sup>225</sup>Ac-J591 and beta-radioligand <sup>177</sup>Lu-PSMA I&amp;T.
Journal of Clinical Oncology2023-06-0110 citations
AlphaBet: Combination of Radium-223 and [177Lu]Lu-PSMA-I&amp;T in men with metastatic castration-resistant prostate cancer (clinical trial protocol)
Frontiers in Medicine2022-11-1840 citations
Abstract CT143: Results of combined targeting of prostate-specific membrane antigen (PSMA) with alpha-radiolabeled antibody 225Ac-J591 and beta-radiolabeled ligand 177Lu-PSMA I&amp;T: preclinical and initial phase 1 clinical data in patients with metastatic castration-resistant prostate cancer (mCRPC)
Cancer Research2022-06-155 citations