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Clinical trial

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

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Last updated:1st Feb 2016

The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Estimated Enrollment: 1100
Study Start Date: February 2016
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Enzalutamide plus androgen deprivation therapy (ADT)
- Placebo Comparator: Placebo plus androgen deprivation therapy (ADT)

Category Value
Study start date 2016-02-01

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