Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (NCT02319837)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (255 Sites)
Showing the first 25 of 255 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Alabama at Birmingham, IDS Pharmacy — Birmingham, Alabama
- Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska
- Arizona Urology Specialists — Tucson, Arizona
- Tower Hematology Oncology Medical Group — Beverly Hills, California
- Cedars-Senai OCC Pharmacy — Los Angeles, California
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California
- University of California, Irvine Medical Center — Orange, California
- Sutter Medical Group, Vascular & Varicose Vein Center — Roseville, California
- Sutter Medical Group — Roseville, California
- UC Davis Comprehensive Cancer Center — Sacramento, California
- University of California Davis Medical Center — Sacramento, California
- University of California, Davis, School of Medicine — Sacramento, California
- The Urology Center of Colorado — Denver, Colorado
- Foothills Urology, P.C. — Golden, Colorado
- Eastern Connecticut Hematology Oncology Associates — Norwich, Connecticut
- Lakeland Regional Health Hollis Cancer Center — Lakeland, Florida
- Emory University Hospital — Atlanta, Georgia
- Winship Cancer Institute, Emory University — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- Northwestern Medical Group — Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois
- First Urology, PSC — Jeffersonville, Indiana
- The University of Kansas Hospital — Kansas City, Kansas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.