Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Timeline

Start

2013-10-22

Primary completion

2016-11-15

Completion

2022-08-31

Outcome

Missed primary endpoint

registry Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg vs Placebo+Abiraterone 1000mg+ Prednisone 10mg; p = 0.2176 NCT01995513 ↗

release “While the PLATO trial did not meet its primary endpoint” pfizer.com ↗

Publications

• Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Background	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

Indications