# ARANOTE

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

## TL;DR

ARANOTE showed that darolutamide added to hormone therapy alone, without chemotherapy, delayed the progression of newly metastatic prostate cancer on scans, extending the drug's use to men who cannot or do not want to have docetaxel.

## Summary

ARASENS had established darolutamide with docetaxel and androgen deprivation for metastatic hormone-sensitive prostate cancer. ARANOTE randomised 669 men with metastatic hormone-sensitive disease two to one to androgen deprivation therapy with darolutamide or with placebo, without docetaxel. The primary endpoint was radiographic progression-free survival.

Darolutamide lengthened radiographic progression-free survival with a tolerability profile again close to placebo, and the result led to approval of darolutamide with androgen deprivation alone for metastatic hormone-sensitive disease in 2025. It gave darolutamide the same two-drug indication that apalutamide (TITAN) and enzalutamide (ARCHES, ENZAMET) already held.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT04736199
- Phase: 3
- Setting: Metastatic hormone-sensitive prostate cancer: androgen deprivation with darolutamide or placebo, without docetaxel
- Sponsor: Bayer
- Enrolled: 669
- Result: Darolutamide plus androgen deprivation lengthened radiographic progression-free survival compared with androgen deprivation alone; approved for this use in 2025.
- Outcomes: Radiological progression-free survival by central review (registry results): Darolutamide + androgen deprivation therapy vs Placebo + androgen deprivation therapy 25 months, HR 0.541

## Notes

- In England NICE TA1109 recommends darolutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable, and instructs prescribers to use the least expensive of the suitable treatments, which includes apalutamide with androgen deprivation, taking account of administration costs, dosages, price per dose and commercial arrangements. Darolutamide with androgen deprivation and docetaxel is covered separately by TA903.

## Sources

- ClinicalTrials.gov NCT04736199: https://clinicaltrials.gov/study/NCT04736199
- NICE TA1109: darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer: https://www.nice.org.uk/guidance/ta1109

## 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/)
- 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: [A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC](https://onco.cc/trials/nct02489318/), [ARASENS](https://onco.cc/trials/arasens/)
- people: [Fred Saad](https://onco.cc/people/fred-saad/)
- key papers: [Darolutamide Plus Androgen-deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase 3 ARANOTE Trial](https://onco.cc/key-papers/paper-aranote-eur-urol-2026/)

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