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

NCT02319837

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the ProstateSafety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
NCT02319837
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Anchorage, Alaska
  5. Tucson, Arizona
  6. Beverly Hills, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Orange, California
  10. Roseville, California
  11. Sacramento, California
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  13. Sacramento, California
  14. Denver, Colorado
  15. Golden, Colorado
  16. Norwich, Connecticut
  17. Washington, District of Columbia
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  19. Lakeland, Florida
  20. Atlanta, Georgia
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  24. Chicago, Illinois
  25. Chicago, Illinois
  26. Jeffersonville, Indiana
  27. Kansas City, Kansas
  28. Overland Park, Kansas
  29. Westwood, Kansas
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  31. Wichita, Kansas
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  49. Uniondale, New York
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  62. Bala-Cynwyd, Pennsylvania
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  64. Philadelphia, Pennsylvania
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  68. Myrtle Beach, South Carolina
  69. Nashville, Tennessee
  70. Nashville, Tennessee
  71. Dallas, Texas
  72. Houston, Texas
  73. San Antonio, Texas
  74. Henrico, Virginia
  75. Richmond, Virginia
  76. Richmond, Virginia
  77. Virginia Beach, Virginia
  78. Gateshead, New South Wales
  79. Lismore, New South Wales
  80. Liverpool, New South Wales
  81. North Ryde, New South Wales
  82. North Sydney, New South Wales
  83. Port Macquarie, New South Wales
  84. St Leonards, New South Wales
  85. Tweed Heads, New South Wales
  86. Wahroonga, New South Wales
  87. Wahroonga, New South Wales
  88. Waratah, New South Wales
  89. Westmead, New South Wales
  90. Wollongong, New South Wales
  91. Westmead, NEW
  92. Auchenflower, Queensland
  93. Chermside, Queensland
  94. South Brisbane, Queensland
  95. South Brisbane, Queensland
  96. Southport, Queensland
  97. Adelaide, South Australia
  98. Box Hill, Victoria
  99. Clayton, Victoria
  100. Heidelberg, Victoria
  101. Malvern, Victoria
  102. St Albans, Victoria
  103. Murdoch, Western Australia
  104. Linz, Upper Austria
  105. Linz,
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  110. Vienna,
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  120. Campinas, SP
  121. Santo Andre, SP
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  123. Edmonton, Alberta
  124. Vancouver, British Columbia
  125. Winnipeg, Manitoba
  126. Halifax, Nova Scotia
  127. Barrie, Ontario
  128. Kingston, Ontario
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  130. Kingston, Ontario
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  132. London, Ontario
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  178. Orbassano (TO),
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  181. Ravenna,
  182. Ravenna,
  183. Ravenna,
  184. Rimini,
  185. Rimini,
  186. Roma,
  187. Roma,
  188. Roma,
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  190. Trento,
  191. Trento,
  192. Trento,
  193. Seongnam-si, Gyeonggi-do
  194. Yangsan-si, Gyeongsangnam-do
  195. Hwasun-gun, Jeollanam-do
  196. Incheon,
  197. Seoul,
  198. Seoul,
  199. Seoul,
  200. Seoul,
  201. Amsterdam,
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  204. Eindhoven,
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  219. Nitra,
  220. Presov,
  221. Zilina,
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  223. Manresa, Barcelona
  224. Sabadell, Barcelona
  225. Santiago de Compostela, LA Coruna
  226. Barcelona,
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  230. Madrid,
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  249. Taipei,
  250. Taoyuan,
  251. Glasgow, CITY OF Glasgow
  252. Wonford, Exeter, Devon
  253. London, Greater London
  254. Sutton, Surrey
  255. Birmingham, WEST Midlands
  256. Bristol,
  257. Glasgow,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hormone Sensitive Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate
Intervention  ICMJE
  • Drug: Enzalutamide
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Placebo
    Sugar pill to mimic enzalutamide
  • Drug: Leuprolide
    Other Names:
    • Eligard
    • Leuprolide Acetate
    • Leuprorelin
    • Lupron
Study Arms  ICMJE
  • Experimental: Enzalutamide plus leuprolide
    Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks
    Interventions:
    • Drug: Enzalutamide
    • Drug: Leuprolide
  • Experimental: Enzalutamide monotherapy
    Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
    Intervention: Drug: Enzalutamide
  • Active Comparator: Placebo plus leuprolide
    Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks
    Interventions:
    • Drug: Placebo
    • Drug: Leuprolide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
1068
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2014)
1860
Estimated Study Completion Date  ICMJE September 19, 2026
Estimated Primary Completion Date September 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-? 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   Denmark,   Finland,   France,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02319837
Other Study ID Numbers  ICMJE MDV3100-13
C3431004 ( Other Identifier: Alias Study Number )
2014-001634-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP