Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Summary
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
Timeline
- Start
- 2021-02-23
- Primary completion
- 2024-06-07
- Completion
- 2026-01-23
Outcome
Met primary endpoint
registry analysis (superiority test); Darolutamide+ADT vs Placebo+ADT; p <0.0001; Hazard Ratio (HR) 0.541 (95% CI 0.413 to 0.707) NCT04736199 ↗
paper darolutamide plus ADT significantly improved rPFS, reducing the risk of radiological progression or death by 46% versus placebo plus ADT PMID 39279580 ↗
release “The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.” bayer.com ↗
release “The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS.” orionpharma.com ↗
release “ARANOTE trial, which showed that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46%” bayer.com ↗
release “ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46%” bayer.com ↗
Publications
- Saad F, Shore N, Vjaters E, Olmos D, Littleton N, Testa I, Mo M, Verholen F, Srinivasan S, Haresh KP. Darolutamide Plus Androgen-deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase 3 ARANOTE Trial. Eur Urol. 2026 Aug 12:S0302-2838(26)02313-4. doi: 10.1016/j.eururo.2026.07.026. Online ahead of print.
- Morgans AK, Haresh KP, Jievaltas M, Olmos D, Shore ND, Vjaters E, Xing N, Mohamed AF, Littleton N, Srinivasan S, Verholen F, Saad F. Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 May;27(5):614-624. doi: 10.1016/S1470-2045(26)00014-8. Epub 2026 Apr 9.
- Saad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, Cesar de Andrade Mota A, Salman P, Jievaltas M, Ulys A, Jakubovskis M, Kopyltsov E, Han W, Nevalaita L, Testa I, Le Berre MA, Kuss I, Haresh KP; ARANOTE Study Investigators. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. doi: 10.1200/JCO-24-01798. Epub 2024 Sep 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | Oral |