Who is eligible for clinical trial NCT02319837?

Participants must meet protocol criteria for Hormone Sensitive Prostate Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT02319837 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-07

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (NCT02319837)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Pfizer

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (9 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (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.

🏛️ View Official NIH Record ↗