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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

NCT02319837 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1068

Last updated 2026-05-07

Study results available
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Summary

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

Conditions

Interventions

DRUG

Enzalutamide

DRUG

Placebo (No longer applicable in Open Label study period)

Sugar pill to mimic enzalutamide

DRUG

Leuprolide Open Label

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-17
Primary Completion
2023-01-31
Completion
2026-09-19

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • Denmark
  • Finland
  • France
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319837 on ClinicalTrials.gov