Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
NCT02319837 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Placebo (No longer applicable in Open Label study period)
- DRUG Leuprolide Open Label
Study Locations (20)
California
- Tower Hematology Oncology Medical Group — Beverly Hills
- Cedars-Senai OCC Pharmacy — Los Angeles
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles
- University of California, Irvine Medical Center — Orange
- Sutter Medical Group, Vascular & Varicose Vein Center — Roseville
- Sutter Medical Group — Roseville
- UC Davis Comprehensive Cancer Center — Sacramento
- University of California Davis Medical Center — Sacramento
- University of California, Davis, School of Medicine — Sacramento
Alabama
- University of Alabama at Birmingham — Birmingham
- University of Alabama at Birmingham, IDS Pharmacy — Birmingham
- University of Alabama at Birmingham — Birmingham
Colorado
- The Urology Center of Colorado — Denver
- Foothills Urology, P.C. — Golden
Georgia
- Emory University Hospital — Atlanta
- Winship Cancer Institute, Emory University — Atlanta
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage
Arizona
- Urological Associates of Southern Arizona, PC — Tucson
Connecticut
- Eastern Connecticut Hematology Oncology Associates — Norwich
Florida
- Lakeland Regional Health Hollis Cancer Center — Lakeland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,068 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02319837
The ClinicalTrials.gov registry entry for NCT02319837 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,068 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02319837 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Alabama, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02319837 about?
NCT02319837 is a clinical study titled "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)". 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...
What is the current status of trial NCT02319837?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2014-12-17. Estimated completion is 2026-09-19.
What conditions does trial NCT02319837 study?
This clinical trial studies the following conditions: Prostate Cancer, Cancer of the Prostate, Hormone Sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02319837?
The interventions under investigation include: Enzalutamide (DRUG), Placebo (No longer applicable in Open Label study period) (DRUG), Leuprolide Open Label (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02319837?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02319837 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.