A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Phase 3 Active, not recruiting NCT01946204

Condition	Prostatic Neoplasms
Phase	Phase 3
Sponsor	Aragon Pharmaceuticals, Inc.
Status	Active, not recruiting
Enrollment	1,207 participants
Interventions	Apalutamide
Start date	Oct 14, 2013
Completion date	May 19, 2017
Results posted	Jun 19, 2018

Summary

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)

Up to approximately 43 Months · Months

Placebo	16.20 Months
Apalutamide	40.51 Months
Placebo	15.70 Months
Apalutamide	40.51 Months

p-value	<0.0001
Hazard Ratio (HR)	0.280 (95% CI 0.227–0.346)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery — Wake Forest University Health Sciences
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced P — National Cancer Institute (NCI)
M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castr — National Cancer Institute (NCI)
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abirate — Janssen Research & Development, LLC
Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Ola — National Cancer Institute (NCI)
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Pr — Janssen Research & Development, LLC

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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