Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
3期
进行中（已停止招募）
NCT02319837
| 适应症 | Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate |
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| 分期 | 3期 |
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| 申办方 | Pfizer |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 1,068 人 |
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| 干预（药物） | Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label |
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| 开始日期 | 2014年12月17日 |
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| 完成日期 | 2023年1月31日 |
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| 结果公布日 | 2024年3月25日 |
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摘要
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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