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



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:December 17, 2014
End Date:July 31, 2023

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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

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.


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
We found this trial at
72
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Anchorage, AK
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Atlanta, Georgia 30322
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Atlanta, Georgia 30322
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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216 North Broad Street
Bala-Cynwyd, Pennsylvania 19004
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Beverly Hills, California 90211
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Birmingham, AL
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Chicago, Illinois 60611
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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4777 East Galbraith Road
Cincinnati, Ohio 45236
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Dallas, Texas 75231
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Denver, Colorado 80211
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Durham, North Carolina 27710
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2301 Erwin Road
Durham, North Carolina 27710
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1020 New River Parkway
Fallon, Nevada 89406
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36 Pacific Highway
Gateshead, New South Wales 2290
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Golden, Colorado 80401
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Greensboro, North Carolina
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500 Westchester Avenue
Harrison, New York 10604
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Henrico, Virginia 23229
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Houston, Texas 77027
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Jeffersonville, Indiana 47130
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Kansas City, Kansas 66160
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3525 Lakeland Hills Boulevard
Lakeland, Florida 33805
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Lancaster, Pennsylvania 17604
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Los Angeles, California 90048
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17405 Hall Road
Macomb, Michigan 48044
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Middleburg Heights, Ohio 44130
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Middleburg Heights, Ohio 44130
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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1301 Medical Center Drive
Nashville, Tennessee 37232
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1211 Medical Center Drive
Nashville, Tennessee 37232
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1275 York Avenue
New York, New York 10065
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353 East 68th Street
New York, New York 10065
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330 Washington St #220
Norwich, Connecticut 06360
(860) 886-8362
Eastern Connecticut Hematology and Oncology Associates In 1985 Dr. Dennis Slater moved from Memorial Sloan-Kettering...
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73104
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Overland Park, Kansas 66211
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833 Chestnut Street
Philadelphia, Pennsylvania 19107
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132 South 10th Street
Philadelphia, Pennsylvania 19107
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3 Crescent Drive
Philadelphia, Pennsylvania 19107
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Richmond, Virginia 23235
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1 Medical Plaza Drive
Roseville, California 95661
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1310 North Stephenson Highway
Royal Oak, Michigan 48067
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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San Antonio, Texas 78229
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Springfield, Oregon 97477
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Virginia Beach, Virginia 23462
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5255 Loughboro Road Northwest
Washington, District of Columbia 20016
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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3901 Rainbow Boulevard
Westwood, Kansas 66205
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