# ARASENS

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

## TL;DR

Proved 'triplet therapy': adding darolutamide to hormone therapy plus chemotherapy reduces death by a third.

## Summary

ARASENS, trial NCT02799602 sponsored by Bayer and Orion and reported in 2022, proved triplet therapy in metastatic hormone-sensitive prostate cancer: adding darolutamide to androgen deprivation plus docetaxel reduces the risk of death by about a third compared with hormone therapy and docetaxel alone. It randomised 1,306 men and met its primary overall survival endpoint, with benefit in both high-volume and low-volume subgroups. OnCo links it to prostate cancer, darolutamide, docetaxel and Matthew R. Smith, and its result is consistent with PEACE-1, which tested an abiraterone triplet in de novo metastatic disease. Because every patient received docetaxel, the trial cannot say whether the chemotherapy was needed on top of darolutamide, which is the main open question. Darolutamide has its own page.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT02799602
- Phase: 3
- Setting: Metastatic hormone-sensitive prostate cancer: ADT + docetaxel + darolutamide vs ADT + docetaxel
- Sponsor: Bayer / Orion
- Enrolled: 1306
- Result: OS HR 0.68.
- Outcomes: Overall survival: Darolutamide + ADT + docetaxel vs Placebo + ADT + docetaxel 48.9 months, HR 0.68
- Replication: Consistent with PEACE-1 (abiraterone triplet) in de novo metastatic disease.

## Notes

- In England NICE TA903 recommends darolutamide with docetaxel within its marketing authorisation for hormone-sensitive metastatic prostate cancer, subject to the commercial arrangement. The committee noted that usual treatment always includes androgen deprivation, given alone or with docetaxel or enzalutamide, and accepted both the direct trial evidence and an indirect comparison against usual treatment.

## Sources

- ClinicalTrials.gov NCT02799602: https://clinicaltrials.gov/study/NCT02799602
- NICE TA903: darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer: https://www.nice.org.uk/guidance/ta903

## 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: [Darolutamide](https://onco.cc/drugs/darolutamide/), [Docetaxel](https://onco.cc/drugs/docetaxel/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- terms: [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/)
- trials: [ARANOTE](https://onco.cc/trials/aranote/), [CHAARTED (E3805)](https://onco.cc/trials/chaarted/), [PEACE-1](https://onco.cc/trials/peace-1/)
- people: [Matthew R. Smith](https://onco.cc/people/matthew-smith/)
- key papers: [ARASENS: darolutamide added to androgen deprivation and docetaxel in metastatic hormone-sensitive prostate cancer](https://onco.cc/key-papers/paper-arasens-nejm-2022/)
- 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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