Clinical Trial: NCT02319837
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2026-07-09 |
Study Overview
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.
The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
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
Conditions
Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
Intervention / Treatment
- Drug: Enzalutamide
- Drug: Placebo (No longer applicable in Open Label study period)
- Drug: Leuprolide Open Label
Other Study ID Numbers
- MDV3100-13
- C3431004
- 2024-513521-23-00
Start Date (Actual)
2014-12-17
Primary Completion Date (Actual)
2023-01-31
Study Completion Date (Estimated)
2026-09-19
Enrollment (Actual)
1068
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2026-07-09 |
Study Overview
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.
The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
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
Conditions
Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
Intervention / Treatment
- Drug: Enzalutamide
- Drug: Placebo (No longer applicable in Open Label study period)
- Drug: Leuprolide Open Label
Other Study ID Numbers
- MDV3100-13
- C3431004
- 2024-513521-23-00
Start Date (Actual)
2014-12-17
Primary Completion Date (Actual)
2023-01-31
Study Completion Date (Estimated)
2026-09-19
Enrollment (Actual)
1068
Study Type
Interventional
Phase
Phase 3