A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 13 Oct 2017
At a glance
- Drugs Abiraterone acetate (Primary) ; LHRH receptor agonists; Prednisone
- Indications Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms LATITUDE
- Sponsors Janssen Research & Development
- 13 Oct 2017 According to a Janssen-Cilag media release, based on the data from this study, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for ZYTIGA (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications.
- 21 Sep 2017 Status changed from recruiting to active, no longer recruiting.
- 18 Sep 2017 According to a Janssen Biotech media release, based on the data of this study, Janssen Biotech has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of ZYTIGA in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naive prostate cancer (HNPC) or newly diagnosed, high risk metastatic hormone sensitive prostate cancer (HSPC).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History