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Showed that treating a fast-rising PSA after surgery or radiation with enzalutamide delays spread.
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. OnCo 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.
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.
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% |
Shares Metastasis-free survival (MFS), Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Enzalutamide.
Shares EMBARK: enzalutamide with or without leuprolide in high-risk biochemically recurrent prostate cancer, Biochemical recurrence of prostate cancer, Prostate cancer.
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Enzalutamide.
Shares GETUG-AFU 16, RADICALS-HD, Biochemical recurrence of prostate cancer, Prostate cancer.
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares STOMP, Biochemical recurrence (BCR), Biochemical recurrence of prostate cancer, Prostate cancer.
Shares PSA doubling time, Metastasis-free survival (MFS), Prostate cancer drugs in England: what NICE recommends, and what it refuses, Biochemical recurrence of prostate cancer.