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177Lu-PSMA-I&T

DRUG6 trials

Sponsors

Curium Pet France, Universitetssykehuset Nord-Norge HF, Weill Medical College of Cornell University, Curium US LLC, Peter MacCallum Cancer Centre, Australia

Conditions

Metastasis From Malignant Tumor of ProstateMetastatic Castrate Resistant Prostate Cancer (mCRPC)Metastatic castration-resistant prostate cancerProstate 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
RecruitingNCT04886986
Weill Medical College of Cornell UniversityProstate Cancer
Start: 2021-06-30End: 2029-12-01Target: 42Updated: 2026-06-11
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
RecruitingNCT07316686
Instituto do Cancer do Estado de São PauloProstate Cancer (Adenocarcinoma)
Start: 2026-06-16End: 2026-12-01Target: 18Updated: 2026-08-25

Phase 2

A single-arm pilot study to investigate tumor absorbed dose dynamics and feasibility of pre-treatment dosimetry with [177Lu]-PSMA-I&T in male participants aged ≥ 18 years with metastatic castration-resistant prostate cancer
Not yet recruitingCTIS2026-526519-12-00
Universitetssykehuset Nord-Norge HFMetastatic castration-resistant prostate cancer
Target: 3Updated: 2026-10-13

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: 2029-02-01Updated: 2026-09-04
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