Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
NCT ID: NCT02799602
Last Updated: 2025-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1306 participants
INTERVENTIONAL
2016-11-30
2023-04-11
Brief Summary
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Detailed Description
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The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.
Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the investigator or his/her designated associate(s), death, non-compliance, or if sponsor terminates the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel
Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
BAY1841788 / darolutamide (ODM-201)
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
Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.
Docetaxel
As prescribed by the treating physician.
Placebo + standard ADT + Docetaxel
Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.
Docetaxel
As prescribed by the treating physician.
Placebo
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.
Interventions
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BAY1841788 / darolutamide (ODM-201)
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
Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.
Docetaxel
As prescribed by the treating physician.
Placebo
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Charleston, South Carolina, United States
Greenville, South Carolina, United States
Myrtle Beach, South Carolina, United States
North Charleston, South Carolina, United States
Dallas, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Falls Church, Virginia, United States
Richmond, Virginia, United States
Everett, Washington, United States
Milwaukee, Wisconsin, United States
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
Kurralta Park, South Australia, Australia
Fitzroy, Victoria, Australia
Wilrijk, Antwerpen, Belgium
Antwerp, , Belgium
Brussels, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Gilly, , Belgium
Namur, , Belgium
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Natal, Rio Grande do Norte, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Gabrovo, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vratsa, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Hefei City, Anhui Province, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shengyang, Liaoning, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Jinan, Shandong, China
Yantai, Shandong, China
Xi’an, Shanxi, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Brno, , Czechia
Brno, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Helsinki, Uusimaa, Finland
Jyväskylä, , Finland
Kuopio, , Finland
Mikkeli, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Angers, , France
Besançon, , France
Bordeaux, , France
Brest, , France
Cergy-Pontoise, , France
Clermont-Ferrand, , France
Créteil, , France
Dijon, , France
Marseille, , France
Montpellier, , France
Nancy, , France
Paris, , France
Pierre-Bénite, , France
Poitiers, , France
Reims, , France
Saint-Grégoire, , France
Saint-Herblain, , France
Saint-Mandé, , France
Strasbourg, , France
Villejuif, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Nürtingen, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Braunschweig, Lower Saxony, Germany
Rostock, Mecklenburg-Vorpommern, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Bologna, Emilia-Romagna, Italy
Parma, Emilia-Romagna, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Novara, Piedmont, Italy
Turin, Piedmont, Italy
Trento, Trentino-Alto Adige, Italy
Cortona, Tuscany, Italy
Padua, Veneto, Italy
Verona, Veneto, Italy
Nagoya, Aichi-ken, Japan
Hirosaki, Aomori, Japan
Asahi, Chiba, Japan
Chiba, Chiba, Japan
Kashiwa, Chiba, Japan
Sakura, Chiba, Japan
Matsuyama, Ehime, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Kanazawa, Ishikawa-ken, Japan
Kita-gun, Kagawa-ken, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Kashihara, Nara, Japan
Okayama, Okayama-ken, Japan
Osaka, Osaka, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Hamamatsu, Shizuoka, Japan
Shimotsuke, Tochigi, Japan
Utsunomiya, Tochigi, Japan
Bunkyo-Ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Yonago, Tottori, Japan
Ube, Yamaguchi, Japan
Chiba, , Japan
Fukuoka, , Japan
Gifu, , Japan
Kumamoto, , Japan
Miyazaki, , Japan
Nagasaki, , Japan
Osaka, , Japan
Tokushima, , Japan
Wakayama, , Japan
Mexico City, Mexico City, Mexico
México, D. F., Mexico City, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo León, Mexico
Querétaro City, Querétaro, Mexico
Mazatlán, Sinaloa, Mexico
Durango, , Mexico
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Dordrecht, , Netherlands
Geleen, , Netherlands
Hilversum, , Netherlands
Hoofddorp, , Netherlands
Nijmegen, , Netherlands
The Hague, , Netherlands
Tilburg, , Netherlands
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Rybnik, , Poland
Siedlce, , Poland
Waliszew, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barnaul, , Russia
Chelyabinsk, , Russia
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Gwangju, Gwangju Gwang''yeogsi, South Korea
Guri-si, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggido, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Sabadell, Barcelona, Spain
Palma de Mallorca, Illes Baleares, Spain
Málaga, Málaga, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Cáceres, , Spain
Córdoba, , Spain
Lugo, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Colchester, Essex, United Kingdom
Romford, Essex, United Kingdom
Middlesbrough, Yorkshire, United Kingdom
Belfast, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Chandler, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Duarte, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Miami Beach, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Camden, New Jersey, United States
Englewood, New Jersey, United States
Hackensack, New Jersey, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Concord, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Gahanna, Ohio, United States
Kettering, Ohio, United States
Oklahoma City, Oklahoma, United States
Bala-Cynwyd, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2015-002590-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17777
Identifier Type: -
Identifier Source: org_study_id
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