Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
Фаза 3
Идёт, набор закрыт
NCT02319837
| Заболевание | Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate |
|---|
| Фаза | Фаза 3 |
|---|
| Спонсор | Pfizer |
|---|
| Статус | Идёт, набор закрыт |
|---|
| Участники | 1,068 участн. |
|---|
| Вмешательство | Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label |
|---|
| Дата начала | 17.12.2014 |
|---|
| Дата завершения | 31.01.2023 |
|---|
| Публикация результатов | 25.03.2024 |
|---|
Кратко
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 |
|---|
| Placebo + Leuprolide | NA Months |
|---|
| p-value | <0.0001 |
|---|
| Hazard Ratio (HR) | 0.424 (95% CI 0.296–0.607) |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.