Prostate Cancer Clinical Trial
ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
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.
Full Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 290 Locations for this study
Chandler Arizona, 85224, United States
Tucson Arizona, 85724, United States
Beverly Hills California, 90211, United States
Duarte California, 91010, United States
Los Angeles California, 90073, United States
Stanford California, 94305, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Gainesville Florida, 32610, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Peoria Illinois, 61615, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21231, United States
Towson Maryland, 21204, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Billings Montana, 59102, United States
Omaha Nebraska, 68130, United States
Lebanon New Hampshire, 03756, United States
Camden New Jersey, 08143, United States
Englewood New Jersey, 07361, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87109, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Kettering Ohio, 45409, United States
Oklahoma City Oklahoma, 73104, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Camp Hill Pennsylvania, 17011, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29607, United States
Myrtle Beach South Carolina, 29572, United States
North Charleston South Carolina, 29406, United States
Dallas Texas, 75231, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23298, United States
Everett Washington, 98201, United States
Milwaukee Wisconsin, 53226, United States
Randwick New South Wales, 2031, Australia
Sydney New South Wales, 2010, Australia
Adelaide South Australia, 5000, Australia
Kurralta Park South Australia, 5037, Australia
Melbourne Victoria, 3065, Australia
Wilrijk Antwerpen, 2610, Belgium
Bruxelles - Brussel , 1000, Belgium
Bruxelles - Brussel , 1070, Belgium
Bruxelles - Brussel , 1200, Belgium
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Namur , 5000, Belgium
Salvador Bahia, 41253, Brazil
Cachoeiro de Itapemirim Espírito Santo, 29308, Brazil
Curitiba Parana, 81520, Brazil
Natal Rio Grande Do Norte, 59040, Brazil
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Santo André Sao Paulo, 09060, Brazil
São Paulo Sao Paulo, 04014, Brazil
Rio de Janeiro , 20231, Brazil
Rio de Janeiro , 22793, Brazil
Gabrovo , 5300, Bulgaria
Pleven , 5809, Bulgaria
Sofia , 1303, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1784, Bulgaria
Varna , 9010, Bulgaria
Vratsa , 3000, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L 4, Canada
Hefei Anhui, 23000, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51012, China
Shijiazhuang Hebei, 05000, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43003, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13000, China
Shengyang Liaoning, 11004, China
Shenyang Liaoning, 11000, China
Xi'an Shaanxi, 71006, China
Jinan Shandong, 25001, China
Jinan Shandong, 25002, China
Yantai Shandong, 26400, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Wenzhou Zhejiang, 32500, China
Beijing , 10003, China
Beijing , 10005, China
Beijing , 10008, China
Beijing , 10014, China
Beijing , 10073, China
Chongqing , 40003, China
Shanghai , 20003, China
Shanghai , 20004, China
Shanghai , 20007, China
Shanghai , 20008, China
Shanghai , 20009, China
Tianjin , 30005, China
Tianjin , 30006, China
Brno , 602 0, Czechia
Brno , 656 9, Czechia
Praha 10 , 10034, Czechia
Praha 2 , 120 0, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 150 0, Czechia
Praha 8 , 180 8, Czechia
Helsinki , 00290, Finland
Jyväskylä , 40620, Finland
Kuopio , 70210, Finland
Mikkeli , FIN-5, Finland
Oulu , 90220, Finland
Tampere , 33521, Finland
Turku , 20520, Finland
Angers Cedex , 49055, France
Besancon , 25030, France
Bordeaux Cedex , 33076, France
Brest , 29200, France
Cergy Pontoise , 95303, France
Clermont-ferrand , 63011, France
Creteil , 94010, France
Marseille , 13273, France
Montpellier Cedex , 34298, France
Nancy , 54100, France
Pierre Benite , 69495, France
Poitiers , 86021, France
REIMS cedex , 51726, France
Saint Herblain Cedex , 44805, France
Saint-gregoire , 35760, France
Strasbourg , 67033, France
Villejuif Cedex , 94805, France
Freiburg Baden-Württemberg, 79106, Germany
Nürtingen Baden-Württemberg, 72622, Germany
Tübingen Baden-Württemberg, 72076, Germany
Ulm Baden-Württemberg, 89075, Germany
Erlangen Bayern, 91054, Germany
Rostock Mecklenburg-Vorpommern, 18107, Germany
Braunschweig Niedersachsen, 38126, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Jena Thüringen, 07747, Germany
Berlin , 12203, Germany
Magdeburg , 39120, Germany
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Holon , 58220, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49414, Israel
Tel Aviv , 64239, Israel
Zefat , 13110, Israel
Zrifin , 70300, Israel
Bologna Emilia-Romagna, 40138, Italy
Parma Emilia-Romagna, 43126, Italy
Roma Lazio, 00152, Italy
Milano Lombardia, 20141, Italy
Novara Piemonte, 28100, Italy
Torino Piemonte, 10043, Italy
Trento Trentino-Alto Adige, 38100, Italy
Padova Veneto, 35128, Italy
Verona Veneto, 37134, Italy
Nagoya Aichi, 466-8, Japan
Hirosaki Aomori, 036-8, Japan
Asahi Chiba, 289-2, Japan
Kashiwa Chiba, 277-8, Japan
Sakura Chiba, 285-8, Japan
Matsuyama Ehime, 791-0, Japan
Sapporo Hokkaido, 003-0, Japan
Kobe Hyogo, 650-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Kita Kagawa, 761-0, Japan
Yokohama Kanagawa, 232-0, Japan
Yokohama Kanagawa, 241-8, Japan
Tsu Mie, 514-8, Japan
Sendai Miyagi, 980-8, Japan
Kashihara Nara, 634-8, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Hamamatsu Shizuoka, 431-3, Japan
Shimotsuke Tochigi, 329-0, Japan
Utsunomiya Tochigi, 321-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Koto-ku Tokyo, 135-8, Japan
Meguro-ku Tokyo, 152-8, Japan
Minato-ku Tokyo, 105-8, Japan
Mitaka Tokyo, 181-8, Japan
Nakano-ku Tokyo, 164-8, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Shinjuku-ku Tokyo, 162-8, Japan
Yonago Tottori, 683-8, Japan
Ube Yamaguchi, 755-8, Japan
Chiba , 260-8, Japan
Chiba , 260-8, Japan
Fukuoka , 811-1, Japan
Gifu , 500-8, Japan
Kumamoto , 860-0, Japan
Miyazaki , 889-1, Japan
Nagasaki , 852-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Osaka , 545-8, Japan
Tokushima , 770-8, Japan
Wakayama , 641-8, Japan
Gwangju Gwangju Gwang''yeogsi, 61469, Korea, Republic of
Seongnam-si Gyeonggido, 13620, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06273, Korea, Republic of
Busan , 47392, Korea, Republic of
Daegu , 41404, Korea, Republic of
Gyeonggi-do , 11923, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Ciudad de Mexico Distrito Federal, 06760, Mexico
México, D. F. Distrito Federal, 06760, Mexico
Cuernavaca Morelos, 62290, Mexico
Monterrey Nuevo Leon, 64460, Mexico
Santiago de Querétaro Querétaro, 76000, Mexico
Mazatlán Sinaloa, 82110, Mexico
Amsterdam , 1066 , Netherlands
Amsterdam , 1105 , Netherlands
Den Haag , 2545 , Netherlands
Dordrecht , 3318 , Netherlands
Geleen , 6162 , Netherlands
Hilversum , 1213 , Netherlands
Hoofddorp , 2134 , Netherlands
Tilburg , 5042 , Netherlands
Lodz , 90-30, Poland
Lublin , 20-36, Poland
Rybnik , 44-20, Poland
Siedlce , 08-11, Poland
Waliszew , 05-13, Poland
Warszawa , 02-78, Poland
Barnaul , 65604, Russian Federation
Chelyabinsk , 45404, Russian Federation
Chelyabinsk , 45408, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12528, Russian Federation
Novosibirsk , 63009, Russian Federation
Omsk , 64401, Russian Federation
St. Petersburg , 18866, Russian Federation
St. Petersburg , 19401, Russian Federation
St. Petersburg , 19713, Russian Federation
Sabadell Barcelona, 08208, Spain
Palma De Mallorca Illes Baleares, 7120, Spain
Barcelona , 08003, Spain
Barcelona , 08023, Spain
Barcelona , 08041, Spain
Barcelona , 8036, Spain
Cáceres , 10003, Spain
Córdoba , 14004, Spain
Lugo , 27003, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Valencia , 46009, Spain
Göteborg , 413 4, Sweden
Lund , 221 8, Sweden
Solna , 171 6, Sweden
Umeå , 901 8, Sweden
Uppsala , 751 8, Sweden
Kaohsiung , 807, Taiwan
Taichung , 40447, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 33305, Taiwan
Colchester Essex, CO4 5, United Kingdom
Romford Essex, RM7 0, United Kingdom
Middlesborough North Yorkshire, TS43B, United Kingdom
Belfast , BT9 7, United Kingdom
Glasgow , G12 0, United Kingdom
London , NW1 2, United Kingdom
London , SW3 6, United Kingdom
London , W6 8R, United Kingdom
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