Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy

Phase 2 Terminated 71 enrolled Endocyte

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Timeline

Start: 2017-07-12
Primary completion: 2020-01-15
Completion: 2020-01-15

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment was stopped before the target sample size was achieved.”

Publications

Gafita A, Calais J, Grogan TR, Hadaschik B, Wang H, Weber M, Sandhu S, Kratochwil C, Esfandiari R, Tauber R, Zeldin A, Rathke H, Armstrong WR, Robertson A, Thin P, D'Alessandria C, Rettig MB, Delpassand ES, Haberkorn U, Elashoff D, Herrmann K, Czernin J, Hofman MS, Fendler WP, Eiber M. Nomograms to predict outcomes after 177Lu-PSMA therapy in men with metastatic castration-resistant prostate cancer: an international, multicentre, retrospective study. Lancet Oncol. 2021 Aug;22(8):1115-1125. doi: 10.1016/S1470-2045(21)00274-6. Epub 2021 Jul 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	177Lu-PSMA-617	Other / unclassified	6000 mbq	Intravenous
Subject	177Lu-PSMA-617	Other / unclassified	7400 mbq	Intravenous