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

NCT02319837 · tracked via the Priya Life Science China tracker

Sponsor

Pfizer

Phase

Phase 3

Started

2014-12-17

Last updated

2026-07-09

Condition(s) studied

Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate

Investigational drug(s) / intervention(s)

Enzalutamide →Placebo (No longer applicable in Open Label study period)Leuprolide Open Label

Placebo (No longer applicable in Open Label study period): Sugar pill to mimic enzalutamide

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). 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

Primary outcome measure(s)

Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide — From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.

Trial sites (255)

Facility	City	Region
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
Kansas City Urology Care, PA	Overland Park	Kansas
The University of Kansas Cancer Center and Medical Pavilion	Westwood	Kansas
GU Research Network/Wichita Urology Group	Wichita	Kansas
John Hopkins University Hospital	Baltimore	Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services	Baltimore	Maryland
Chesapeake Urology Research Associates	Towson	Maryland
Comprehensive Urology - Macomb Office	Macomb	Michigan
Comprehensive Urology - Royal Oak (Stephenson) office	Royal Oak	Michigan
GU Research Network, LLC / Urology Cancer Center	Omaha	Nebraska
VA Lahontan Valley Outpatient Clinic	Fallon	Nevada
Memorial Sloan Kettering Cancer Center Basking Ridge	Basking Ridge	New Jersey
Memorial Sloan Kettering Cancer Center Commack	Commack	New York
Memorial Sloan Kettering Cancer Center Westchester	Harrison	New York
Memorial Hospital	New York	New York

+ 215 more sites — see the full list on the official registry below.

On this site

📄 Xtandi (enzalutamide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02319837 on ClinicalTrials.gov ↗ ← All trials in China