EMBARK
Showed that treating a fast-rising PSA after surgery or radiation with enzalutamide delays spread.
Overview
EMBARK, trial NCT02319837 sponsored by Pfizer and Astellas and reported in 2023, showed that treating a fast-rising PSA after surgery or radiotherapy with enzalutamide delays the appearance of metastases. It randomised 1,068 men with high-risk biochemical recurrence, defined by a PSA doubling time of nine months or less, to enzalutamide plus leuprolide, enzalutamide alone or leuprolide alone, suspending treatment if the PSA became undetectable at 36 weeks, and met its primary metastasis-free survival endpoint for the combination; approval followed in November 2023 and a survival benefit for the combination was reported in 2025. Nuclide links it to prostate cancer, enzalutamide and the biochemical recurrence term. Whether treating a rising PSA early beats waiting for imaging-detected disease, now that PSMA PET finds it sooner, is the open question.
- 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 enrolled.
Survival over time
Step lines join published landmark estimates; the true curve between them is not shown.
Curves show the trial population; they are not a prediction for any one person.
| 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 to 0.61) | <0.001 | link |
| Leuprolide alone, 5-year MFS | 358 | 71.4% |
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