# ARAMIS: darolutamide in non-metastatic castration-resistant prostate cancer

Source: https://onco.cc/key-papers/paper-aramis-nejm-2019/  
OnCo record `paper-aramis-nejm-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Darolutamide, an androgen receptor inhibitor that barely enters the brain, delayed metastases by nearly two years in men with non-metastatic castration-resistant prostate cancer with side effects close to placebo, and later showed a survival benefit.

## Summary

Phase 3 placebo-controlled trial of 1,509 men with non-metastatic castration-resistant prostate cancer and PSA doubling time of ten months or less randomised 2:1 to darolutamide or placebo with continued androgen deprivation.

Median metastasis-free survival was 40.4 versus 18.4 months (hazard ratio 0.41), three-year overall survival 83 versus 77 percent (hazard ratio 0.69 at final analysis), and adverse events including falls, fractures, seizures and cognitive impairment were similar to placebo.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2019
- DOI: 10.1056/NEJMoa1815671
- Authors: Fizazi K, Shore N, Tammela TL, et al.
- Findings: Median metastasis-free survival 40.4 vs 18.4 months; hazard ratio 0.41.; Overall survival hazard ratio 0.69; adverse event rates close to placebo.
- What it means: Darolutamide is often preferred in older men or those with fall or cognitive concerns because of its favourable tolerability among the three approved agents.
- Caveats: No head-to-head comparison with enzalutamide or apalutamide.; Non-metastatic by conventional imaging.

## Sources

- N Engl J Med 2019: https://doi.org/10.1056/NEJMoa1815671
- PubMed: https://pubmed.ncbi.nlm.nih.gov/30763142/

## Connected records

- cancers: [Non-metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-nmcrpc/)
- drugs: [Darolutamide](https://onco.cc/drugs/darolutamide/)
- trials: [ARAMIS](https://onco.cc/trials/aramis/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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