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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319837
Recruitment Status : Active, not recruiting
First Posted : December 18, 2014
Last Update Posted : April 27, 2023
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate Drug: Enzalutamide Drug: Placebo Drug: Leuprolide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1068 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 17, 2014
Actual Primary Completion Date : January 31, 2023
Estimated Study Completion Date : September 19, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi

Drug: Leuprolide
Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron
Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
 Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi
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
 Drug: Placebo
Sugar pill to mimic enzalutamide

Drug: Leuprolide
Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron


Outcome Measures
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Primary Outcome Measures :
  1. Metastasis-free survival (MFS) [ Time Frame: Up to approximately 90 months ]
    Compared between enzalutamide plus leuprolide and placebo plus leuprolide.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 132 months ]
  2. Time to castration resistance [ Time Frame: Up to approximately 90 months ]
  3. Composite of safety [ Time Frame: Up to approximately 90 months ]
    Safety will be evaluated by the incidence of serious adverse events, incidence and severity of adverse events, incidence of permanent treatment discontinuation due to adverse events, and incidence of new clinically significant changes in clinical laboratory values and vital signs.

  4. Metastasis-free survival (MFS) [ Time Frame: Up to approximately 90 months ]
    Compared between enzalutamide monotherapy versus placebo plus leuprolide.

  5. Time to prostate specific antigen (PSA) progression; [ Time Frame: Up to approximately 90 months ]
  6. Time to first use of new antineoplastic therapy [ Time Frame: Up to approximately 90 months ]
  7. Time to distant metastasis [ Time Frame: Up to approximately 90 months ]
  8. Proportion of patients per group who remain treatment free 2 years after suspension of study drug treatment at week 37 due to undetectable PSA [ Time Frame: From baseline (week 37) up to 90 months ]
  9. Proportion of patients per group with undetectable PSA 2 years after suspension of study drug treatment at week 37 due to undetectable PSA [ Time Frame: From baseline (week 37) up to 90 months ]
  10. Proportion of patients per group with undetectable PSA at 36 weeks on study drug [ Time Frame: At week 36 ]
  11. Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA [ Time Frame: From baseline (week 37) up to 90 months ]
  12. Time to symptomatic progression [ Time Frame: Up to approximately 90 months ]
  13. Time to first symptomatic skeletal event [ Time Frame: Up to approximately 90 months ]
  14. Time to clinically relevant pain [ Time Frame: Up to approximately 90 months ]
  15. Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire, [ Time Frame: Up to approximately 90 months ]
  16. Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L), [ Time Frame: Up to approximately 90 months ]
  17. Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module [ Time Frame: Up to approximately 90 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319837


Locations
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Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators
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Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02319837    
Other Study ID Numbers: MDV3100-13
C3431004 ( Other Identifier: Alias Study Number )
2014-001634-28 ( EudraCT Number )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents