- Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) — Active Not Recruiting • Phase III • Oncology • NCT02319837.
- Enzalutamide plus leuprolide safely improved outcomes in high-risk prostate cancer patients who progressed after surgery or radiotherapy.
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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: Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate Interventions: Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label Lead Sponsor: Pfizer Planned Enrollment: 1068 participants