Trials / Active Not Recruiting
Active Not RecruitingNCT02319837
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,068 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzalutamide | |
| DRUG | Placebo (No longer applicable in Open Label study period) | Sugar pill to mimic enzalutamide |
| DRUG | Leuprolide Open Label |
Timeline
- Start date
- 2014-12-17
- Primary completion
- 2023-01-31
- Completion
- 2026-09-19
- First posted
- 2014-12-18
- Last updated
- 2025-07-08
- Results posted
- 2024-03-25
Locations
247 sites across 17 countries: United States, Australia, Austria, Brazil, Canada, Denmark, Finland, France, Italy, Netherlands, Poland, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT02319837. Inclusion in this directory is not an endorsement.