{"commentary":{"count":305,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":124,"x_thread":113,"podcast":68},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02799602\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"ARASENS","nct_id":"NCT02799602","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=arasens-nct02799602. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"ARASENS","arms":[{"description":"Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel","label":"BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel","type":"EXPERIMENTAL"},{"description":"Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel","label":"Placebo + standard ADT + Docetaxel","type":"PLACEBO_COMPARATOR"}],"collaborators":["Orion Corporation, Orion Pharma"],"completion_date":{"date":"2023-04-11","type":"ACTUAL"},"conditions":["Metastatic Hormone-sensitive Prostate Cancer"],"enrollment":{"count":1306,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"BAY1841788 / darolutamide (ODM-201)","type":"DRUG"},{"name":"Standard ADT (androgen deprivation therapy)","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2025-12-04","lead_sponsor":"Bayer","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","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-10-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"OS From Date of Randomization Until Death From Any Cause - Number of Events","timeFrame":"From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)"},{"measure":"OS From Date of Randomization Until Death From Any Cause - Month","timeFrame":"From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)"}],"references":[{"citation":"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.","pmid":"42833883","type":"DERIVED"},{"citation":"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.","pmid":"36795843","type":"DERIVED"},{"citation":"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.","pmid":"35656777","type":"DERIVED"},{"citation":"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.","pmid":"35179323","type":"DERIVED"}],"start_date":{"date":"2016-11-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT02799602"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/arasens-nct02799602"}