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Clinical Trial Active — Not Recruiting Phase III NCT02319837

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) — Active Not Recruiting • Phase III • Oncology • NCT02319837.

📅 07 May 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT02319837
Start
2014-12-17
Completion
2023-01-31
ClinicaliQ Trial Snapshot
  • 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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What This Trial Is Studying

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Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate Interventions: Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label Lead Sponsor: Pfizer Planned Enrollment: 1068 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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