You are here

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

Last updated on April 19, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
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-? 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

NCT02319837
Pfizer
Recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC), Diffuse Large B-Cell Lymphoma (DLBCL)
NCT03460977
All Genders
18+
Years
Multiple Sites
Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
NCT02573259
All Genders
18+
Years
Multiple Sites
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT02499120
All Genders
18+
Years
Multiple Sites
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hormone Sensitive Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate
  • Drug: Enzalutamide
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Placebo
    Sugar pill to mimic enzalutamide
  • Drug: Leuprolide
    Other Names:
    • Eligard
    • Leuprolide Acetate
    • Leuprorelin
    • Lupron
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1860
June 13, 2024
March 31, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Austria,   Brazil,   Canada,   Denmark,   Finland,   France,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
 
 
NCT02319837
MDV3100-13
C3431004 ( Other Identifier: Alias Study Number )
2014-001634-28 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now