Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Phase 3
Active, not recruiting
NCT02319837
| Condition | Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate |
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| Phase | Phase 3 |
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| Sponsor | Pfizer |
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| Status | Active, not recruiting |
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| Enrollment | 1,068 participants |
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| Interventions | Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label |
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| Start date | Dec 17, 2014 |
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| Completion date | Jan 31, 2023 |
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| Results posted | Mar 25, 2024 |
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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.
Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide
From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups) · Months
| Enzalutamide + Leuprolide | NA Months |
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| Placebo + Leuprolide | NA Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.424 (95% CI 0.296–0.607) |
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Open in BENITIONS
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