ClinicalTrials.gov record
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
ClinicalTrials.gov ID: NCT02319837
Public ClinicalTrials.gov record NCT02319837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02319837
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,068 participants
Conditions and interventions
Interventions
- Enzalutamide Drug
- Placebo (No longer applicable in Open Label study period) Drug
- Leuprolide Open Label Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2014 (Actual)
- Primary completion
- Jan 31, 2023 (Actual)
- Completion
- Sep 19, 2026 (Estimated)
- Last update posted
- Jul 9, 2026
2014 – 2026
United States locations
- U.S. sites
- 77
- U.S. states
- 26
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| University of Alabama at Birmingham, IDS Pharmacy | Birmingham | Alabama | 35294 | — |
| Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage | Alaska | 99503 | — |
| Arizona Urology Specialists | Tucson | Arizona | 85741 | — |
| Tower Hematology Oncology Medical Group | Beverly Hills | California | 90211 | — |
| Cedars-Senai OCC Pharmacy | Los Angeles | California | 90048 | — |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | — |
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
| Sutter Medical Group, Vascular & Varicose Vein Center | Roseville | California | 95661 | — |
| Sutter Medical Group | Roseville | California | 95661 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California, Davis, School of Medicine | Sacramento | California | 95817 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Foothills Urology, P.C. | Golden | Colorado | 80401 | — |
| Eastern Connecticut Hematology Oncology Associates | Norwich | Connecticut | 06360 | — |
| Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | 33805 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | — |
| Emory University Hospital | Atlanta | Georgia | 30329 | — |
| Northwestern Medical Group | Chicago | Illinois | 60611 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| First Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Kansas City Urology Care, PA | Overland Park | Kansas | 66211 | — |
| The University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | 66205 | — |
| GU Research Network/Wichita Urology Group | Wichita | Kansas | 67226 | — |
| John Hopkins University Hospital | Baltimore | Maryland | 21287 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services | Baltimore | Maryland | 21287 | — |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | — |
| Comprehensive Urology - Macomb Office | Macomb | Michigan | 48044 | — |
| Comprehensive Urology - Royal Oak (Stephenson) office | Royal Oak | Michigan | 48067 | — |
| GU Research Network, LLC / Urology Cancer Center | Omaha | Nebraska | 68130 | — |
| VA Lahontan Valley Outpatient Clinic | Fallon | Nevada | 89406 | — |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Cancer Center Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center Westchester | Harrison | New York | 10604 | — |
| Memorial Hospital | New York | New York | 10065 | — |
| Sidney Kimmel Center for Prostate and Urologic Cancers | New York | New York | 10065 | — |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12601 | — |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12603 | — |
| Memorial Sloan Kettering Cancer Center Rockville Centre | Rockville Centre | New York | 11570 | — |
| Associated Medical Professionals of New York, PLLC | Syracuse | New York | 13210 | — |
| Memorial Sloan Kettering Cancer Center Nassau | Uniondale | New York | 11553 | — |
| Duke Investigational Chemotherapy Services | Durham | North Carolina | 27710 | — |
| Duke Nuclear Medicine | Durham | North Carolina | 27710 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Alliance Urology Specialists, PA | Greensboro | North Carolina | 27403 | — |
| TriState Urologic Services PSC Inc., dba The Urology Group | Cincinnati | Ohio | 45212 | — |
| Mercy Health Jewish Hospital | Cincinnati | Ohio | 45236 | — |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | — |
| Southwest Urology | Middleburg Heights | Ohio | 44130 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Imaging Center | Eugene | Oregon | 97401 | — |
| Oregon Urology Institute | Springfield | Oregon | 97477 | — |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Keystone Urology Specialists | Lancaster | Pennsylvania | 17604 | — |
| Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization | Philadelphia | Pennsylvania | 19083 | — |
| Honickman Centre | Philadelphia | Pennsylvania | 19107 | — |
| Jefferson Medical Oncology | Philadelphia | Pennsylvania | 19107 | — |
| Jefferson Urology Associates | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital, Bodine Building | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University, Medical Oncology | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | 19107 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Vanderbilt Urology Clinic Cool Springs | Franklin | Tennessee | 37067 | — |
| Vanderbilt Health Belle Meade | Nashville | Tennessee | 37205 | — |
| The Vanderbilt Clinic, Department of Urology | Nashville | Tennessee | 37232 | — |
| Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery | Nashville | Tennessee | 37232 | — |
| Urology Clinics of North Texas, PLLC | Dallas | Texas | 75231 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Urology San Antonio Research | San Antonio | Texas | 78229 | — |
| Henrico Doctor's Hospital | Henrico | Virginia | 23229 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
| Urology of Virginia, PLLC. | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 178 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02319837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02319837 live on ClinicalTrials.gov.