Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
ARASENS
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
2 other identifiers
interventional
1,306
23 countries
322
Brief Summary
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
Longer than P75 for phase_3
322 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedStudy Start
First participant enrolled
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedResults Posted
Study results publicly available
February 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2023
CompletedDecember 4, 2025
November 1, 2025
4.9 years
June 6, 2016
October 25, 2022
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
OS From Date of Randomization Until Death From Any Cause - Number of Events
Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
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)
OS From Date of Randomization Until Death From Any Cause - Month
Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study. Median, percentile and other 95% CIs were computed using Kaplan-Meier estimates. NA = Value cannot be estimated due to censored data
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)
Secondary Outcomes (15)
Number of Participants With TEAEs
From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
Time to Castration-Resistant Prostate Cancer (CRPC) - Month
From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
Time to Pain Progression - Number of Events
From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
Time to Pain Progression - Month
From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
- +10 more secondary outcomes
Study Arms (2)
BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel
EXPERIMENTALCo-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
Placebo + standard ADT + Docetaxel
PLACEBO COMPARATORCo-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
Interventions
600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel
As prescribed by the treating physician.
As prescribed by the treating physician.
Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Metastatic disease
- Candidates for ADT and docetaxel.
- Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver and renal function
You may not qualify if:
- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
- Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
- Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
- Inability to swallow oral medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Orion Corporation, Orion Pharmacollaborator
Study Sites (322)
Unknown Facility
Chandler, Arizona, 85224, United States
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Tucson, Arizona, 85724, United States
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Beverly Hills, California, 90211, United States
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Duarte, California, 91010, United States
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Los Angeles, California, 90073, United States
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Palo Alto, California, 94304, United States
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Denver, Colorado, 80211, United States
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Washington D.C., District of Columbia, 20007, United States
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Boca Raton, Florida, 33486, United States
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Gainesville, Florida, 32610, United States
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Miami Beach, Florida, 33140, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Peoria, Illinois, 61615, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21287, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114-2696, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Billings, Montana, 59102, United States
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Omaha, Nebraska, 68130, United States
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Lebanon, New Hampshire, 03756, United States
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Camden, New Jersey, 08103, United States
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Englewood, New Jersey, 07361, United States
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Hackensack, New Jersey, 07601, United States
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Albuquerque, New Mexico, 87109, United States
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Buffalo, New York, 14203, United States
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New York, New York, 10032, United States
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Poughkeepsie, New York, 12603, United States
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Rochester, New York, 14642, United States
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The Bronx, New York, 14061, United States
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Concord, North Carolina, 28025, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 43210, United States
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Gahanna, Ohio, 43230, United States
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Kettering, Ohio, 45409, United States
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Oklahoma City, Oklahoma, 73104, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Camp Hill, Pennsylvania, 17011, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Charleston, South Carolina, 29401, United States
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Charleston, South Carolina, 29414, United States
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Greenville, South Carolina, 29607, United States
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Myrtle Beach, South Carolina, 29579, United States
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North Charleston, South Carolina, 29406, United States
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Dallas, Texas, 75231, United States
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Temple, Texas, 76508, United States
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Salt Lake City, Utah, 84112, United States
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Charlottesville, Virginia, 22903, United States
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Falls Church, Virginia, 22042, United States
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Richmond, Virginia, 23284, United States
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Everett, Washington, 98201, United States
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Milwaukee, Wisconsin, 53226, United States
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Sydney, New South Wales, 2010, Australia
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Sydney, New South Wales, 2031, Australia
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Adelaide, South Australia, 5000, Australia
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Kurralta Park, South Australia, 5037, Australia
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Fitzroy, Victoria, 3065, Australia
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Wilrijk, Antwerpen, 2610, Belgium
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Antwerp, 2020, Belgium
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Brussels, 1070, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Ghent, 9000, Belgium
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Gilly, 6060, Belgium
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Namur, 5000, Belgium
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Cachoeiro de Itapemirim, Espírito Santo, 29308-020, Brazil
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Salvador, Estado de Bahia, 41253-190, Brazil
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Belo Horizonte, Minas Gerais, 30130-100, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Natal, Rio Grande do Norte, 59040-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Santo André, São Paulo, 09060-650, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 04014-002, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São Paulo, 01308-050, Brazil
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Gabrovo, 5300, Bulgaria
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Pleven, 5809, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1784, Bulgaria
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Varna, 9010, Bulgaria
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Vratsa, 3000, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Hefei City, Anhui Province, Anhui, 230031, China
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Beijing, Beijing Municipality, 100034, China
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Beijing, Beijing Municipality, 100142, China
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Beijing, Beijing Municipality, 100730, China
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Xiamen, Fujian, 361003, China
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Guangzhou, Guangdong, 510120, China
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Shijiazhuang, Hebei, 50000, China
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Zhengzhou, Henan, 450000, China
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Wuhan, Hubei, 430030, China
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Wuhan, Hubei, 430079, China
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Changsha, Hunan, 410013, China
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Nanjing, Jiangsu, 210000, China
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Nanjing, Jiangsu, 210008, China
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Nanchang, Jiangxi, 330006, China
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Changchun, Jilin, 130061, China
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Shengyang, Liaoning, 110042, China
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Shenyang, Liaoning, 110001, China
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Jinan, Shandong, 250000, China
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Jinan, Shandong, 250021, China
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Yantai, Shandong, 264000, China
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Xi’an, Shanxi, 710061, China
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Hangzhou, Zhejiang, 310009, China
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Hangzhou, Zhejiang, 310014, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100050, China
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Beijing, 100083, China
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Beijing, 100730, China
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Chongqing, 400030, China
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Shanghai, 200000, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shanghai, 200072, China
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Shanghai, 200080, China
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Shanghai, 200092, China
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Tianjin, 300000, China
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Tianjin, 300052, China
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Brno, 656 91, Czechia
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Brno, 65653, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 10034, Czechia
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Prague, 120 00, Czechia
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Prague, 12808, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Helsinki, Uusimaa, 00029, Finland
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Jyväskylä, 40620, Finland
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Kuopio, FIN- 70029, Finland
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Mikkeli, FIN-50100, Finland
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Oulu, 90220, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Angers, 49055, France
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Besançon, 25030, France
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Bordeaux, 33076, France
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Brest, 29200, France
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Cergy-Pontoise, 95303, France
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Clermont-Ferrand, 63011, France
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Créteil, 94010, France
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Dijon, 21000, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nancy, 54100, France
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Paris, 75248, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Reims, 51726, France
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Saint-Grégoire, 35760, France
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Saint-Herblain, 44805, France
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Saint-Mandé, 94160, France
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Strasbourg, 67033, France
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Villejuif, 94805, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Nürtingen, Baden-Wurttemberg, 72622, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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Erlangen, Bavaria, 91054, Germany
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Braunschweig, Lower Saxony, 38126, Germany
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Rostock, Mecklenburg-Vorpommern, 18107, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Dresden, Saxony, 1307, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Jena, Thuringia, 7747, Germany
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Berlin, 12203, Germany
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Beersheba, 8410101, Israel
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Haifa, 3109601, Israel
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Holon, 5822012, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 4941492, Israel
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Safed, 1311001, Israel
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Tel Aviv, 6423906, Israel
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Ẕerifin, 7030000, Israel
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Bologna, Emilia-Romagna, 40138, Italy
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Parma, Emilia-Romagna, 43126, Italy
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Rome, Lazio, 152, Italy
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Milan, Lombardy, 20141, Italy
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Novara, Piedmont, 28100, Italy
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Turin, Piedmont, 10043, Italy
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Trento, Trentino-Alto Adige, 38100, Italy
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Cortona, Tuscany, 52040, Italy
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Padua, Veneto, 35128, Italy
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Verona, Veneto, 37134, Italy
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Nagoya, Aichi-ken, 466-8560, Japan
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Hirosaki, Aomori, 036-8563, Japan
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Asahi, Chiba, 289-2511, Japan
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Chiba, Chiba, 260-8677, Japan
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Kashiwa, Chiba, 277-8577, Japan
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Sakura, Chiba, 285-8741, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Sapporo, Hokkaido, 003-0804, Japan
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Kobe, Hyōgo, 650-0017, Japan
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Kanazawa, Ishikawa-ken, 920-8530, Japan
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Kanazawa, Ishikawa-ken, 920-8641, Japan
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Kita-gun, Kagawa-ken, 761-0793, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Yokohama, Kanagawa, 241-8515, Japan
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Tsu, Mie-ken, 514-8507, Japan
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Sendai, Miyagi, 980-8574, Japan
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Kashihara, Nara, 634-8522, Japan
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Okayama, Okayama-ken, 700-8558, Japan
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Osaka, Osaka, 541-8567, Japan
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Sakai, Osaka, 590-0197, Japan
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Suita, Osaka, 565-0871, Japan
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Hamamatsu, Shizuoka, 431-3192, Japan
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Shimotsuke, Tochigi, 329-0498, Japan
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Utsunomiya, Tochigi, 321-0974, Japan
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Bunkyo-Ku, Tokyo, 113-0022, Japan
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Bunkyo-ku, Tokyo, 113-8431, Japan
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Bunkyo-ku, Tokyo, 113-8655, Japan
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Koto-ku, Tokyo, 135-8550, Japan
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Meguro-ku, Tokyo, 152-8902, Japan
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Minato-ku, Tokyo, 105-8471, Japan
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Mitaka, Tokyo, 181-8611, Japan
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Nakano-ku, Tokyo, 164-8541, Japan
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Shinjuku-ku, Tokyo, 160-8582, Japan
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Shinjuku-ku, Tokyo, 162-8543, Japan
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Yonago, Tottori, 683-8504, Japan
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Ube, Yamaguchi, 755-8505, Japan
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Chiba, 260-8717, Japan
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Fukuoka, 811-1395, Japan
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Gifu, 500-8717, Japan
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Kumamoto, 860-0008, Japan
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Miyazaki, 889-1692, Japan
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Nagasaki, 852-8501, Japan
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Osaka, 545-8586, Japan
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Tokushima, 770-8503, Japan
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Wakayama, 640-8558, Japan
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Mexico City, Mexico City, 6760, Mexico
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México, D. F., Mexico City, 6760, Mexico
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Cuernavaca, Morelos, 62290, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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Querétaro City, Querétaro, 76000, Mexico
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Mazatlán, Sinaloa, 82110, Mexico
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Durango, 34000, Mexico
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Geleen, 6162 BG, Netherlands
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Hilversum, 1213 VG, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Nijmegen, 6525 GA, Netherlands
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The Hague, 2545 CH, Netherlands
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Tilburg, 5042 AD, Netherlands
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Lodz, 90-302, Poland
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Lublin, 20-362, Poland
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Poznan, 60-569, Poland
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Rybnik, 44-200, Poland
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Siedlce, 08-110, Poland
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Waliszew, 05-135, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 50-556, Poland
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Barnaul, 656045, Russia
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Chelyabinsk, 454048, Russia
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Chelyabinsk, 454087, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Novosibirsk, 630099, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 188663, Russia
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Saint Petersburg, 194017, Russia
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Saint Petersburg, 197136, Russia
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Gwangju, Gwangju Gwang''yeogsi, 501-757, South Korea
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Guri-si, Gyeonggi-do, 471-701, South Korea
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Seongnam-si, Gyeonggido, 13620, South Korea
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Seoul, Seoul Teugbyeolsi, 03722, South Korea
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Seoul, Seoul Teugbyeolsi, 05505, South Korea
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Seoul, Seoul Teugbyeolsi, 3080, South Korea
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Seoul, Seoul Teugbyeolsi, 6273, South Korea
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Busan, 47392, South Korea
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Daegu, 700721, South Korea
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Seoul, 02841, South Korea
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Seoul, 06351, South Korea
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Seoul, 137-701, South Korea
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Sabadell, Barcelona, 08208, Spain
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Palma de Mallorca, Illes Baleares, 7120, Spain
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Málaga, Málaga, 29010, Spain
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 8036, Spain
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Barcelona, 8041, Spain
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Cáceres, 10003, Spain
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Córdoba, 14004, Spain
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Lugo, 27003, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Valencia, 46009, Spain
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Gothenburg, 413 45, Sweden
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Lund, 222 42, Sweden
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Stockholm, 171 76, Sweden
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Umeå, 901 85, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, Kaohsiung, 807377, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 404327, Taiwan
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Taipei, 100, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan District, 33305, Taiwan
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Colchester, Essex, CO45JR, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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Middlesbrough, Yorkshire, TS43BW, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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London, NW1 2PG, United Kingdom
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London, SW3 6JJ, United Kingdom
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London, W6 8RF, United Kingdom
Related Publications (3)
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: 36795843DERIVEDSmith 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: 35656777DERIVEDSmith 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: 35179323DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 15, 2016
Study Start
November 30, 2016
Primary Completion
October 25, 2021
Study Completion
April 11, 2023
Last Updated
December 4, 2025
Results First Posted
February 24, 2023
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.