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Safety and Efficacy Study of ...

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

NCT ID: NCT02319837

Last Updated: 2025-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1068 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-17

Study Completion Date

2026-09-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The randomized blinded portion of the study has concluded. The study is now being conducted open label manner.

Study Groups

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Enzalutamide plus leuprolide

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks

Group Type EXPERIMENTAL

Enzalutamide

Intervention Type DRUG

Leuprolide Open Label

Intervention Type DRUG

Enzalutamide monotherapy

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Group Type EXPERIMENTAL

Enzalutamide

Intervention Type DRUG

Leuprolide plus placebo

Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks.

The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.

Group Type ACTIVE_COMPARATOR

Placebo (No longer applicable in Open Label study period)

Intervention Type DRUG

Sugar pill to mimic enzalutamide

Interventions

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Enzalutamide

Intervention Type DRUG

Placebo (No longer applicable in Open Label study period)

Sugar pill to mimic enzalutamide

Intervention Type DRUG

Leuprolide Open Label

Intervention Type DRUG

Other Intervention Names

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MDV3100 Xtandi Eligard Leuprolide Acetate Leuprorelin Lupron

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
* Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
* PSA doubling time ≤ 9 months;
* Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
* Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

Exclusion Criteria

* Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
* Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
* Major surgery within 4 weeks before randomization;
* Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, United States

Site Status

Urological Associates of Southern Arizona, PC

Tucson, Arizona, United States

Site Status

Tower Hematology Oncology Medical Group

Beverly Hills, California, United States

Site Status

Cedars-Senai OCC Pharmacy

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Site Status

University of California, Irvine Medical Center

Orange, California, United States

Site Status

Sutter Medical Group, Vascular & Varicose Vein Center

Roseville, California, United States

Site Status

Sutter Medical Group

Roseville, California, United States

Site Status

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

University of California, Davis, School of Medicine

Sacramento, California, United States

Site Status

The Urology Center of Colorado

Denver, Colorado, United States

Site Status

Foothills Urology, P.C.

Golden, Colorado, United States

Site Status

Eastern Connecticut Hematology Oncology Associates

Norwich, Connecticut, United States

Site Status

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

First Urology, PSC

Jeffersonville, Indiana, United States

Site Status

The University of Kansas Hospital

Kansas City, Kansas, United States

Site Status

Kansas City Urology Care, PA

Overland Park, Kansas, United States

Site Status

The University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, United States

Site Status

GU Research Network/Wichita Urology Group

Wichita, Kansas, United States

Site Status

John Hopkins University Hospital

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services

Baltimore, Maryland, United States

Site Status

Chesapeake Urology Research Associates

Towson, Maryland, United States

Site Status

Comprehensive Urology - Macomb Office

Macomb, Michigan, United States

Site Status

Comprehensive Urology - Royal Oak (Stephenson) office

Royal Oak, Michigan, United States

Site Status

GU Research Network, LLC / Urology Cancer Center

Omaha, Nebraska, United States

Site Status

VA Lahontan Valley Outpatient Clinic

Fallon, Nevada, United States

Site Status

Memorial Sloan Kettering Cancer Center Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Westchester

Harrison, New York, United States

Site Status

Memorial Hospital

New York, New York, United States

Site Status

Sidney Kimmel Center for Prostate and Urologic Cancers

New York, New York, United States

Site Status

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Rockville Centre

Rockville Centre, New York, United States

Site Status

Associated Medical Professionals of New York, PLLC

Syracuse, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, New York, United States

Site Status

Duke Investigational Chemotherapy Services

Durham, North Carolina, United States

Site Status

Duke Nuclear Medicine

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Alliance Urology Specialists, PA

Greensboro, North Carolina, United States

Site Status

TriState Urologic Services PSC Inc., dba The Urology Group

Cincinnati, Ohio, United States

Site Status

Mercy Health Jewish Hospital

Cincinnati, Ohio, United States

Site Status

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Site Status

Southwest Urology

Middleburg Heights, Ohio, United States

Site Status

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Imaging Center

Eugene, Oregon, United States

Site Status

Oregon Urology Institute

Springfield, Oregon, United States

Site Status

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Site Status