# ARCHES

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

## TL;DR

Brought enzalutamide into first-line metastatic treatment, with an overall survival benefit confirmed in 2021.

## Summary

ARCHES, trial NCT02677896 sponsored by Astellas and Pfizer and reported in 2019, brought enzalutamide into first-line treatment of metastatic hormone-sensitive prostate cancer, with an overall survival benefit confirmed in 2021. It randomised 1,150 men to androgen deprivation with enzalutamide or placebo, met its primary radiographic progression-free survival endpoint with a large effect, and later showed improved overall survival at the final analysis. OnCo links it to enzalutamide and to Andrew J. Armstrong, and the result was independently confirmed by ENZAMET and is consistent with TITAN for apalutamide, so the class effect is well replicated. Whether treatment intensity can be reduced in men who respond deeply is the open question the field has moved on to. Enzalutamide has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT02677896
- Phase: 3
- Setting: Metastatic hormone-sensitive prostate cancer: ADT + enzalutamide vs ADT
- Sponsor: Astellas / Pfizer
- Enrolled: 1150
- Result: rPFS HR 0.39; OS HR 0.66.
- Outcomes: Radiographic progression-free survival: ADT + enzalutamide vs ADT + placebo 19 months, HR 0.39; Overall survival: ADT + enzalutamide vs ADT + placebo, HR 0.66
- Replication: Replicated by ENZAMET (enzalutamide) and TITAN (apalutamide).

## Notes

- ARCHES and ENZAMET together support the enzalutamide indication in hormone-sensitive metastatic disease that NICE TA712 recommends. TA712 places no restriction on prior docetaxel suitability, unlike TA741 for apalutamide and TA1109 for darolutamide, both of which apply only if docetaxel is not suitable.

## Sources

- ClinicalTrials.gov NCT02677896: https://clinicaltrials.gov/study/NCT02677896
- NICE TA712: enzalutamide for treating hormone-sensitive metastatic prostate cancer: https://www.nice.org.uk/guidance/ta712

## Connected records

- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [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: [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/)
- trials: [A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC](https://onco.cc/trials/nct02489318/), [ENZAMET](https://onco.cc/trials/enzamet/), [KEYNOTE-991](https://onco.cc/trials/keynote-991/)
- people: [Andrew J. Armstrong](https://onco.cc/people/andrew-armstrong/)
- key papers: [ARCHES 5-year Survival with Enzalutamide Plus Androgen-deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer Patients](https://onco.cc/key-papers/paper-arches-eur-urol-2026-update/), [ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer](https://onco.cc/key-papers/paper-arches-j-clin-oncol-2019/)
- 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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