Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc..
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,068actual
Sites
255
Countries
Australia, Austria, Brazil +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2014-12-17 | actual | When the study began enrolling |
| Primary completion | 2023-01-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-19 | estimated | The whole study's end, after follow-up |
| First posted | 2014-12-18 | estimated | When this record first appeared on the registry |
| Results posted | 2024-03-25 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hormone Sensitive Prostate Cancer
- Prostate Cancer
- Cancer of the Prostate
Interventions
- Drug: Enzalutamide — also filed as MDV3100, Xtandi
- Drug: Placebo (No longer applicable in Open Label study period)
- Drug: Leuprolide Open Label — also filed as Eligard, Leuprolide Acetate, Leuprorelin, Lupron
Primary outcome
what the primary-completion date above is the date OFMetastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide
measured 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)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-05-18 · 1.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-06-02 · 870 KB · SAP_001.pdf
Publications
- PMID 42333826 — linked by the registry
- PMID 41364813 — linked by the registry
- PMID 41349040 — linked by the registry
- PMID 41124201 — linked by the registry
- PMID 40140551 — linked by the registry
- PMID 38421252 — linked by the registry
- PMID 38421243 — linked by the registry
- PMID 38320501 — linked by the registry
- PMID 37851874 — linked by the registry
- PMID 37119051 — linked by the registry
- PMID 34385241 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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