Clinical trial · no report yet · Phase 3
ARASENS
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
- NCT02799602 ↗
- Completed
- Bayer
- 305 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 | |
|---|---|---|
| YouTube | 124 | |
| X threads | 113 | |
| Podcasts | 68 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
- Phase
- Phase 3
- Status
- Completed
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- BAY1841788 / darolutamide (ODM-201); Standard ADT (androgen deprivation therapy); Docetaxel; Placebo
- Arms
- BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel · Experimental
- Placebo + standard ADT + Docetaxel · Placebo comparator
- Enrollment
- 1,306
- Primary outcomes
- OS From Date of Randomization Until Death From Any Cause - Number of Events
- OS From Date of Randomization Until Death From Any Cause - Month
- Sponsor
- Bayer with Orion Corporation, Orion Pharma
- Start
- Nov 30, 2016
- Primary completion
- Oct 25, 2021
- Results posted
- Yes
- Registry record
- NCT02799602 · updated Dec 4, 2025
Publications
linked from the registry- Xiao X, Ni X, Zhao Y, Li X, Wang S, Wang H, Ye D, Wu J, Zhu Y. Testosterone breakthrough and outcomes during intensified therapy in metastatic hormone-sensitive prostate cancer: the ARASENS and LATITUDE trials. BJU Int. 2026 Oct 5. doi: 10.1111/bju.70474. Online ahead of print. PubMed 42833883
- Hussain M, Tombal B, Saad F, Fizazi K, Sternberg CN, Crawford ED, Shore N, Kopyltsov E, Kalebasty AR, Bogemann M, Ye D, Cruz F, Suzuki H, Kapur S, Srinivasan S, Verholen F, Kuss I, Joensuu H, Smith MR. Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial. J Clin Oncol. 2023 Jul 10;41(20):3595-3607. doi: 10.1200/JCO.23.00041. Epub 2023 Feb 16. PubMed 36795843
- Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3. PubMed 35656777
- Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17. PubMed 35179323