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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

In brief

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.

Key facts

Study ID

NCT02319837

Run by

Pfizer

People needed

1068

Starts

2014-12-17

Expected to finish

2026-09-19

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham, IDS Pharmacy — Birmingham, Alabama, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States
• Arizona Urology Specialists — Tucson, Arizona, United States
• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• Cedars-Senai OCC Pharmacy — Los Angeles, California, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Sutter Medical Group, Vascular & Varicose Vein Center — Roseville, California, United States
• Sutter Medical Group — Roseville, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California, Davis, School of Medicine — Sacramento, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Foothills Urology, P.C. — Golden, Colorado, United States
• Eastern Connecticut Hematology Oncology Associates — Norwich, Connecticut, United States
• Lakeland Regional Health Hollis Cancer Center — Lakeland, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• First Urology, PSC — Jeffersonville, Indiana, United States
• The University of Kansas Hospital — Kansas City, Kansas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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