# ARAMIS

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

## TL;DR

ARAMIS showed that darolutamide, an androgen receptor blocker that barely enters the brain, delayed metastases and lengthened life in men whose prostate cancer was rising on hormone therapy but not yet visible on scans, with side effects close to placebo.

## Summary

ARAMIS randomised 1509 men with non-metastatic castration-resistant prostate cancer and a PSA doubling time of ten months or less two to one to darolutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.

Darolutamide lengthened metastasis-free survival substantially and improved overall survival in the final analysis, with rates of fatigue, falls, fractures, seizures and cognitive effects that were close to placebo, a tolerability profile attributed to its low penetration of the blood-brain barrier. It was approved in the United States in July 2019 and is often preferred among the three androgen receptor inhibitors for this setting in older men.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02200614
- Phase: 3
- Setting: High-risk non-metastatic castration-resistant prostate cancer: darolutamide against placebo, both with continued androgen deprivation
- Sponsor: Bayer
- Enrolled: 1509
- Result: Darolutamide lengthened metastasis-free and overall survival compared with placebo with a near-placebo side-effect profile; approved in July 2019.
- Outcomes: Metastasis-free survival (planned primary analysis): Darolutamide 40.4 months vs Placebo 18.4 months, HR 0.41; Discontinuation for adverse events: Darolutamide 8.9% vs Placebo 8.7%

## Notes

- In England NICE TA660 recommends darolutamide with androgen deprivation within its marketing authorisation for hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease, subject to the commercial arrangement. The committee noted that the only current option at this stage is to continue androgen deprivation alone, accepted that darolutamide delays spread, and said that although the trial suggests it lengthens life it is unclear by how much in the long term.

## Sources

- ClinicalTrials.gov NCT02200614: https://clinicaltrials.gov/study/NCT02200614
- NICE TA660: darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer: https://www.nice.org.uk/guidance/ta660

## Connected records

- cancers: [Non-metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-nmcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- drugs: [Darolutamide](https://onco.cc/drugs/darolutamide/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- terms: [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/)
- trials: [A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct01946204/), [PROSPER](https://onco.cc/trials/prosper/)
- people: [Karim Fizazi](https://onco.cc/people/karim-fizazi/)
- key papers: [ARAMIS: darolutamide in non-metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-aramis-nejm-2019/)

---
JSON: https://onco.cc/api/v1/entities/aramis.json