Clinical trial · no report yet · Phase 3
ARANOTE
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
- NCT04736199 ↗
- Completed
- Bayer
- 181 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 90 | |
| YouTube | 60 | |
| Podcasts | 30 | |
| X videos | 1 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Prostatic Neoplasms
- Interventions
- Darolutamide (Nubeqa, BAY1841788); Placebo; Androgen deprivation therapy (ADT)
- Arms
- Darolutamide+ADT · Experimental
- Placebo+ADT · Placebo comparator
- Enrollment
- 669
- Primary outcomes
- Radiological Progression-free Survival (rPFS) Assessed by Central Review
- Sponsor
- Bayer with Orion Corporation, Orion Pharma
- Start
- Feb 23, 2021
- Primary completion
- Jun 7, 2024
- Results posted
- Yes
- Registry record
- NCT04736199 · updated Sep 29, 2026
Publications
linked from the registry- 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. PubMed 42586872
- 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. PubMed 41969015
- 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. PubMed 39279580