EMBARK
Showed that treating a fast-rising PSA after surgery or radiation with enzalutamide delays spread.
1,068 men; metastasis-free survival HR 0.42 (combination) and 0.63 (enzalutamide alone) vs leuprolide; treatment suspended if PSA undetectable at 36 weeks. Approval November 2023. OS benefit reported 2025 for the combination.
Setting
High-risk biochemical recurrence (PSA doubling time ≤9 months) after local therapy: enzalutamide + leuprolide, enzalutamide alone, or leuprolide alone
Phase
Phase 3
Sponsor
Pfizer / Astellas
Registry
Headline result
MFS HR 0.42 (combination).
Reported
2023
Enrolled
1068
Replication
Single pivotal trial in high-risk biochemical recurrence; OS immature.
In plain words
What these results mean for people, not percentages
Metastasis-free survival, enzalutamide + leuprolide vs leuprolideprimarysurrogate endpoint
- 87.3 vs 71.4 out of 100 reached this endpoint with Enzalutamide + leuprolide, 5-year MFS compared with Leuprolide alone, 5-year MFS; 15.9 more per 100.
- Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 58 percent lower chance of the event at any given time (hazard ratio 0.42, likely range 0.3 to 0.61).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: High-risk biochemical recurrence (PSA doubling time ≤9 months) after local therapy: enzalutamide + leuprolide, enzalutamide alone, or leuprolide alone. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,068 participants enrolled.
Metastasis-free survival, enzalutamide + leuprolide vs leuprolideprimary
HR 0.42 (0.3–0.61) · p <0.001
Enzalutamide + leuprolide, 5-year MFS87.3 of 100
n = 355
Leuprolide alone, 5-year MFS71.4 of 100
n = 358
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Metastasis-free survival, enzalutamide + leuprolide vs leuprolideprimary | Enzalutamide + leuprolide, 5-year MFS | 355 | 87.3% | 0.42 (0.3–0.61) | <0.001 | link |
| Leuprolide alone, 5-year MFS | 358 | 71.4% |
Replication
Single pivotal trial in high-risk biochemical recurrence; OS immature.