# EMBARK

Source: https://onco.cc/trials/embark/  
OnCo record `embark` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed that treating a fast-rising PSA after surgery or radiation with enzalutamide delays spread.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT02319837
- Phase: 3
- Setting: High-risk biochemical recurrence (PSA doubling time ≤9 months) after local therapy: enzalutamide + leuprolide, enzalutamide alone, or leuprolide alone
- Sponsor: Pfizer / Astellas
- Enrolled: 1068
- Result: MFS HR 0.42 (combination).
- Outcomes: Metastasis-free survival, enzalutamide + leuprolide vs leuprolide: Enzalutamide + leuprolide, 5-year MFS 87.3% vs Leuprolide alone, 5-year MFS 71.4%, HR 0.42
- Replication: Single pivotal trial in high-risk biochemical recurrence; OS immature.

## Notes

- EMBARK sits between the localised and metastatic settings: high-risk biochemical recurrence after local treatment, defined by a PSA doubling time of 9 months or less, with no metastases on conventional imaging. There is no NICE technology appraisal covering enzalutamide in this indication in England, and NICE TA580, the nearest appraisal in a non-metastatic hormone-relapsed population, does not recommend enzalutamide.

## Sources

- ClinicalTrials.gov NCT02319837: https://clinicaltrials.gov/study/NCT02319837
- NICE TA580: enzalutamide for hormone-relapsed non-metastatic prostate cancer, not recommended: https://www.nice.org.uk/guidance/ta580

## Connected records

- cancers: [Biochemical recurrence of prostate cancer](https://onco.cc/cancers/prostate-bcr/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- drugs: [Enzalutamide](https://onco.cc/drugs/enzalutamide/)
- companies: [Astellas](https://onco.cc/companies/astellas/)
- terms: [Biochemical recurrence (BCR)](https://onco.cc/terms/biochemical-recurrence/), [Metastasis-free survival (MFS)](https://onco.cc/terms/metastasis-free-survival/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [PSA doubling time](https://onco.cc/terms/psa-doubling-time/)
- trials: [GETUG-AFU 16](https://onco.cc/trials/getug-afu-16/), [RADICALS-HD](https://onco.cc/trials/radicals-hd/), [STOMP](https://onco.cc/trials/stomp-oligorecurrence/)
- key papers: [EMBARK: enzalutamide with or without leuprolide in high-risk biochemically recurrent prostate cancer](https://onco.cc/key-papers/paper-embark-nejm-2023/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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