# ARASENS: darolutamide added to androgen deprivation and docetaxel in metastatic hormone-sensitive prostate cancer

Source: https://onco.cc/key-papers/paper-arasens-nejm-2022/  
OnCo record `paper-arasens-nejm-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the androgen receptor inhibitor darolutamide to hormone therapy and docetaxel chemotherapy cut deaths by a third in metastatic hormone-sensitive prostate cancer, establishing triplet therapy for men fit for chemotherapy.

## Summary

Phase 3 placebo-controlled trial of 1,306 men with metastatic hormone-sensitive prostate cancer randomised to androgen deprivation plus docetaxel with darolutamide or placebo.

Four-year overall survival was 62.7 versus 50.4 percent (hazard ratio 0.68), with delayed castration resistance, pain progression and skeletal events, and no meaningful increase in toxicity beyond docetaxel; benefit was seen in both high- and low-volume disease.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2022
- DOI: 10.1056/NEJMoa2119115
- Authors: Smith MR, Hussain M, Saad F, et al.
- Findings: Four-year overall survival 62.7 percent vs 50.4 percent; hazard ratio 0.68.; Time to castration-resistant disease hazard ratio 0.36.
- What it means: Triplet therapy with darolutamide is a standard for fit men with metastatic hormone-sensitive prostate cancer, particularly high-volume disease; PEACE-1 showed the same with abiraterone.
- Caveats: No arm of androgen deprivation plus darolutamide without docetaxel, so the contribution of docetaxel is unproven.; Most patients had high-volume disease.

## Sources

- N Engl J Med 2022: https://doi.org/10.1056/NEJMoa2119115
- PubMed: https://pubmed.ncbi.nlm.nih.gov/35179323/

## Connected records

- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/)
- drugs: [Darolutamide](https://onco.cc/drugs/darolutamide/)
- trials: [ARASENS](https://onco.cc/trials/arasens/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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