Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Timeline
- Start
- 2014-09-12
- Primary completion
- 2018-09-03
- Completion
- 2021-06-14
Outcome
Met primary endpoint
registry analysis (superiority test); Darolutamide (BAY1841788) vs Placebo; p <0.000001; Hazard Ratio (HR) 0.413 (95% CI 0.341 to 0.500); Log Rank NCT02200614 ↗
registry MEDIAN Darolutamide (BAY1841788): 40.37 (34.33 to NA) months MEDIAN Placebo: 18.43 (15.51 to 22.34) months NCT02200614 ↗
release “Orion and Bayer have completed the phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer - The primary endpoint was met” orionpharma.com ↗
release “Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS)” orionpharma.com ↗
release “Phase III ARAMIS trial showing darolutamide plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS)” orionpharma.com ↗
release “Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS)” orionpharma.com ↗
release “Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS)” orionpharma.com ↗
Publications
- Saar M, Fizazi K, Shore ND, Smith M, Damber JE, Semenov A, Ribal MJ, Birtle A, Rigaud J, Wallis CJD, Grimm MO, Halabi S, Armstrong AJ, Mohamed AF, Adorjan P, Srinivasan S, Verholen F, Morgans AK, Siemens DR. Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS. Cancer Med. 2026 Jan;15(1):e71343. doi: 10.1002/cam4.71343.
- Ni X, Sui J, Wang B, Wang H, Freedland SJ, Ye D, Zhu Y. Lower Testosterone Level and Metastases-Free Survival in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Novel Antiandrogens: A Post Hoc Analysis of SPARTAN and ARAMIS. J Urol. 2025 Jul;214(1):10-17. doi: 10.1097/JU.0000000000004545. Epub 2025 Mar 25.
- Shore ND, Gratzke C, Feyerabend S, Werbrouck P, Carles J, Vjaters E, Tammela TLJ, Morris D, Aragon-Ching JB, Concepcion RS, Emmenegger U, Fleshner N, Grabbert M, Lietuvietis V, Mahammedi H, Cruz FM, Paula A, Pieczonka C, Rannikko A, Richardet M, Silveira G, Kuss I, Le Berre MA, Verholen F, Sarapohja T, Smith MR, Fizazi K. Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS. Oncologist. 2024 Jul 5;29(7):581-588. doi: 10.1093/oncolo/oyae019.
- Fizazi K, Shore ND, Smith M, Ramos R, Jones R, Niegisch G, Vjaters E, Wang Y, Srinivasan S, Sarapohja T, Verholen F. Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial. Eur J Cancer. 2023 Oct;192:113258. doi: 10.1016/j.ejca.2023.113258. Epub 2023 Jul 27.
- Carles J, Medina-Lopez RA, Puente J, Gomez-Ferrer A, Nebra JC, Saez Medina MI, Ribal MJ, Antolin AR, Alvarez-Ossorio JL, Suarez Novo JF, Agut CM, Srinivasan S, Ortiz J, Fizazi K. Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis. Future Oncol. 2023 Apr;19(12):819-828. doi: 10.2217/fon-2022-1131. Epub 2023 May 24.
- Shore ND, Stenzl A, Pieczonka C, Klaassen Z, Aronson WJ, Karsh L, Ryan CJ, Ortiz J, Srinivasan S, Mohamed AF, Verholen F. Impact of darolutamide on local symptoms: pre-planned and post hoc analyses of the ARAMIS trial. BJU Int. 2023 Apr;131(4):452-460. doi: 10.1111/bju.15887. Epub 2022 Sep 29.
- Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.
- Fizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8.
- Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.
- Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.
- Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | — |