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


Condition: Prostatic Neoplasms

Intervention:

  • Drug: BAY1841788 / darolutamide (ODM-201)
  • Drug: Standard ADT (androgen deprivation therapy)
  • Drug: Docetaxel
  • Drug: Placebo

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02799602

Sponsor: Bayer

Primary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: approximately 70 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to castration resistant prostate cancer
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Time to initiation of subsequent antineoplastic therapy
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Symptomatic skeletal event free survival (SSE-FS)
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Time to first symptomatic skeletal event (SSE)
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Time to initiation of opioid use
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Time to pain progression
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Time to worsening of physical symptoms of disease
  • Time Frame: approximately 70 months
  • Safety Issue:
  • Measure: Number of participants with adverse events as a measure of safety and tolerability
  • Time Frame: approximately 70 months
  • Safety Issue:

Estimated Enrollment: 1300

Study Start Date: November 30, 2016

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Contact:

  • Bayer Clinical Trials Contact
  • (+)1-888-84 22937

Locations:

  • Chandler Arizona 85224 United States
  • Gilbert Arizona 85234 United States
  • Scottsdale Arizona 85259-5452 United States
  • Tucson Arizona 85724 United States
  • Beverly Hills California 90211-1850 United States
  • Duarte California 91010 United States
  • Los Angeles California 90073-1003 United States
  • Stanford California 94305-5820 United States
  • Aurora Colorado 80045 United States
  • Denver Colorado 80211 United States
  • Englewood Colorado 80113-2766 United States
  • New Haven Connecticut 06520 United States
  • Washington District of Columbia 20007-2197 United States
  • Boca Raton Florida 33486 United States
  • Gainesville Florida 32608 United States
  • Miami Beach Florida 33140 United States
  • Tampa Florida 33612 United States
  • Atlanta Georgia 30322 United States
  • Newnan Georgia 30265 United States
  • Chicago Illinois 60611 United States
  • Peoria Illinois 61615-7828 United States
  • Louisville Kentucky 40202 United States
  • New Orleans Louisiana 70112 United States
  • Baltimore Maryland 21287 United States
  • Towson Maryland 21204 United States
  • Boston Massachusetts 02111 United States
  • Boston Massachusetts 02114 United States
  • Boston Massachusetts 02215 United States
  • Burlington Massachusetts 01805 United States
  • Detroit Michigan 48202 United States
  • Billings Montana 59102 United States
  • Omaha Nebraska 68130-5606 United States
  • Lebanon New Hampshire 03756-0001 United States
  • Englewood New Jersey 07361 United States
  • Hackensack New Jersey 07601 United States
  • Voorhees New Jersey 08043 United States
  • Albuquerque New Mexico 87109 United States
  • Bronx New York 10467-2490 United States
  • Buffalo New York 14263-0001 United States
  • New Hyde Park New York 11042 United States
  • New York New York 10032 United States
  • New York New York United States
  • Poughkeepsie New York 12601 United States
  • Rochester New York 14642 United States
  • Syracuse New York 13210 United States
  • Concord North Carolina 28025 United States
  • Winston-Salem North Carolina 27157 United States
  • Cleveland Ohio 44106-2602 United States
  • Columbus Ohio 43210 United States
  • Columbus Ohio 43221-2416 United States
  • Kettering Ohio 45409-1328 United States
  • Oklahoma City Oklahoma 73104 United States
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Camp Hill Pennsylvania 17011 United States
  • Ephrata Pennsylvania 17522-1761 United States
  • Hershey Pennsylvania 17033 United States
  • Philadelphia Pennsylvania 19111-2497 United States
  • Pittsburgh Pennsylvania 15212 United States
  • Providence Rhode Island 02906 United States
  • Charleston South Carolina 29401-5799 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
  • Nashville Tennessee 37209 United States
  • Nashville Tennessee 37232-0021 United States
  • Dallas Texas 75231 United States
  • Houston Texas 77030 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 23219 United States
  • Everett Washington 98201 United States
  • Seattle Washington 98101-2756 United States
  • Seattle Washington 98109-1023 United States
  • Milwaukee Wisconsin 53226 United States
  • Randwick New South Wales 2031 Australia
  • Sydney New South Wales 2010 Australia
  • Adelaide South Australia 5000 Australia
  • Melbourne Victoria 3065 Australia
  • Richmond Victoria 3122 Australia
  • Nedlands Western Australia 6009 Australia
  • Kurralta Park 5037 Australia
  • Wilrijk Antwerpen 2610 Belgium
  • Antwerpen 2020 Belgium
  • Bruxelles - Brussel 1000 Belgium
  • Bruxelles - Brussel 1070 Belgium
  • Bruxelles - Brussel 1200 Belgium
  • Charleroi 6000 Belgium
  • Gent 9000 Belgium
  • Namur 5000 Belgium
  • Salvador Bahia 41253-190 Brazil
  • Cachoeiro de Itapemirim Espírito Santo 29308-020 Brazil
  • Belo Horizonte Minas Gerais 30130-100 Brazil
  • Belo Horizonte Minas Gerais 30150-320 Brazil
  • Curitiba Parana 81520-060 Brazil
  • Natal Rio Grande Do Norte 59062-000 Brazil
  • Porto Alegre Rio Grande Do Sul 90050 170 Brazil
  • Santo André Sao Paulo 09060-650 Brazil
  • São Paulo Sao Paulo 01246-000 Brazil
  • São Paulo Sao Paulo 03102 002 Brazil
  • Rio de Janeiro 20231-050 Brazil
  • Rio de Janeiro 22793-080 Brazil
  • Sao Paulo 01308-050 Brazil
  • Sao Paulo 05651-901 Brazil
  • Gabrovo 5300 Bulgaria
  • Pleven 5800 Bulgaria
  • Plovdiv 4004 Bulgaria
  • Sofia 1303 Bulgaria
  • Sofia 1431 Bulgaria
  • Sofia 1784 Bulgaria
  • Varna 2010 Bulgaria
  • Vratsa 3000 Bulgaria
  • Calgary Alberta T2N 4N2 Canada
  • Edmonton Alberta T6G 1Z2 Canada
  • Toronto Ontario M4N 3M5 Canada
  • Toronto Ontario M5G 2M9 Canada
  • Montreal Quebec H2L 4M1 Canada
  • Hefei Anhui 230001 China
  • Xiamen Fujian 361003 China
  • Guangzhou Guangdong 510120 China
  • Shijiazhuang Hebei 050000 China
  • Zhengzhou Henan 450008 China
  • Wuhan Hubei 430030 China
  • Wuhan Hubei 430079 China
  • Changsha Hunan 410011 China
  • Changsha Hunan 410013 China
  • Nanjing Jiangsu 210008 China
  • Nanjing Jiangsu 210009 China
  • Nanchang Jiangxi 330006 China
  • Changchun Jilin 130021 China
  • Shengyang Liaoning 110042 China
  • Shenyang Liaoning 110001 China
  • Xi'an Shaanxi 710061 China
  • Jinan Shandong 250012 China
  • Jinan Shandong 250021 China
  • Yantai Shandong 264000 China
  • Hangzhou Zhejiang 310009 China
  • Hangzhou Zhejiang 310014 China
  • Wenzhou Zhejiang 325000 China
  • Beijing 100034 China
  • Beijing 100050 China
  • Beijing 100142 China
  • Beijing 100191 China
  • Beijing 100730 China
  • Beijing 100730 China
  • Chongqing 400030 China
  • Shanghai 200032 China
  • Shanghai 200040 China
  • Shanghai 200072 China
  • Shanghai 200080 China
  • Shanghai 200092 China
  • Tianjin 300052 China
  • Tianjin 300060 China
  • Brno 656 53 Czechia
  • Brno 656 91 Czechia
  • Hradec Kralove 500 05 Czechia
  • Praha 10 10034 Czechia
  • Praha 2 120 00 Czechia
  • Praha 2 128 08 Czechia
  • Praha 5 150 06 Czechia
  • Praha 8 180 01 Czechia
  • Helsinki 00029 Finland
  • Jyväskylä 40620 Finland
  • Kuopio 70210 Finland
  • Mikkeli FIN-50100 Finland
  • Oulu 90220 Finland
  • Tampere 33521 Finland
  • Turku 20520 Finland
  • Angers Cedex 49933 France
  • Besancon 25030 France
  • Bordeaux Cedex 33076 France
  • Brest 29200 France
  • Caen Cedex 5 14076 France
  • Clermont-ferrand 63011 France
  • Creteil 94010 France
  • Dijon 21000 France
  • Marseille 13273 France
  • Montpellier Cedex 34298 France
  • Nancy 54100 France
  • PARIS cedex 5 75248 France
  • Paris 75674 France
  • Pierre Benite 69495 France
  • Poitiers 86021 France
  • Pontoise 95301 France
  • Reims 51056 France
  • Saint Herblain Cedex 44805 France
  • Saint Mande 94160 France
  • Saint-gregoire 35760 France
  • Strasbourg 67098 France
  • Villejuif Cedex 94805 France
  • Freiburg Baden-Württemberg 79106 Germany
  • Reutlingen Baden-Württemberg 72766 Germany
  • Tübingen Baden-Württemberg 72076 Germany
  • Ulm Baden-Württemberg 89075 Germany
  • Erlangen Bayern 91054 Germany
  • Rostock Mecklenburg-Vorpommern 18107 Germany
  • Braunschweig Niedersachsen 38118 Germany
  • Düsseldorf Nordrhein-Westfalen 40225 Germany
  • Köln Nordrhein-Westfalen 50931 Germany
  • Münster Nordrhein-Westfalen 48149 Germany
  • Homburg Saarland 66421 Germany
  • Dresden Sachsen 01307 Germany
  • Jena Thüringen 07740 Germany
  • Berlin 12200 Germany
  • Magdeburg 39120 Germany
  • Beer Sheva 8410101 Israel
  • Haifa 3109601 Israel
  • Holon 5810001 Israel
  • Jerusalem 9103102 Israel
  • Jerusalem 9112001 Israel
  • Petah Tikva 4941492 Israel
  • Tel Aviv 6423906 Israel
  • Zefat 1311001 Israel
  • Zerifin 6093000 Israel
  • Bologna Emilia-Romagna 40138 Italy
  • Parma Emilia-Romagna 43126 Italy
  • Roma Lazio 00152 Italy
  • Roma Lazio 00161 Italy
  • Milano Lombardia 20141 Italy
  • Novara Piemonte 28100 Italy
  • Torino Piemonte 10043 Italy
  • Bari Puglia 70124 Italy
  • Arezzo Toscana 52100 Italy
  • Trento Trentino-Alto Adige 38122 Italy
  • Padova Veneto 35128 Italy
  • Verona Veneto 37134 Italy
  • Nagoya Aichi 466-8560 Japan
  • Hirosaki Aomori 036-8563 Japan
  • Asahi Chiba 289-2511 Japan
  • Kashiwa Chiba 277-8577 Japan
  • Sakura Chiba 285-8741 Japan
  • Matsuyama Ehime 791-0280 Japan
  • Sapporo Hokkaido 003-0804 Japan
  • Kobe Hyogo 650-0017 Japan
  • Kanazawa Ishikawa 920-8530 Japan
  • Kanazawa Ishikawa 920-8641 Japan
  • Kita Kagawa 761-0793 Japan
  • Yokohama Kanagawa 232-0024 Japan
  • Yokohama Kanagawa 241-8515 Japan
  • Tsu Mie 514-8507 Japan
  • Sendai Miyagi 980-8574 Japan
  • Kashihara Nara 634-8522 Japan
  • Osakasayama Osaka 589-8511 Japan
  • Suita Osaka 565-0871 Japan
  • Hamamatsu Shizuoka 431-3192 Japan
  • Shimotsuke Tochigi 329-0498 Japan
  • Utsunomiya Tochigi 321-0974 Japan
  • Bunkyo-ku Tokyo 113-8431 Japan
  • Bunkyo-ku Tokyo 113-8603 Japan
  • Bunkyo-ku Tokyo 113-8655 Japan
  • Koto-ku Tokyo 135-8550 Japan
  • Meguro-ku Tokyo 152-8902 Japan
  • Minato-ku Tokyo 105-8471 Japan
  • Mitaka Tokyo 181-8611 Japan
  • Nakano-ku Tokyo 164-8541 Japan
  • Shinjuku-ku Tokyo 160-8582 Japan
  • Shinjuku-ku Tokyo 162-8543 Japan
  • Yonago Tottori 683-8504 Japan
  • Ube Yamaguchi 755-8505 Japan
  • Chiba 260-8677 Japan
  • Chiba 260-8717 Japan
  • Fukuoka 811-1395 Japan
  • Gifu 500-8717 Japan
  • Kumamoto 860-0008 Japan
  • Miyazaki 889-1692 Japan
  • Nagasaki 852-8501 Japan
  • Okayama 700-8558 Japan
  • Osaka 541-8567 Japan
  • Osaka 545-8586 Japan
  • Tokushima 770-8503 Japan
  • Wakayama 641-8509 Japan
  • Donggu, Gwangju Gwang''yeogsi 501-757 Korea, Republic of
  • Seongnam-si Gyeonggido 463-707 Korea, Republic of
  • Seoul Seoul Teugbyeolsi 135-720 Korea, Republic of
  • Busan 614-735 Korea, Republic of
  • Daegu 41404 Korea, Republic of
  • Gyeonggi-do 471-701 Korea, Republic of
  • Seoul 03080 Korea, Republic of
  • Seoul 05505 Korea, Republic of
  • Seoul 120-752 Korea, Republic of
  • Seoul 135-710 Korea, Republic of
  • Seoul 136-705 Korea, Republic of
  • Seoul 137-701 Korea, Republic of
  • Ciudad de Mexico Distrito Federal 06760 Mexico
  • Mexico Distrito Federal 06700 Mexico
  • México Distrito Federal 14080 Mexico
  • Cuernavaca Morelos 62290 Mexico
  • Monterrey Nuevo Leon 64460 Mexico
  • Mazatlán Sinaloa 82110 Mexico
  • Cuautitlan Izcalli 54769 Mexico
  • Durango 34000 Mexico
  • Mexico CP 14050 Mexico
  • Querétaro 76000 Mexico
  • Amsterdam 1066 CX Netherlands
  • Amsterdam 1105 AZ Netherlands
  • Den Haag 2545 CH Netherlands
  • Dordrecht 3318 AT Netherlands
  • Heerlen 6401 CX Netherlands
  • Hilversum 1213 XZ Netherlands
  • Hoofddorp 2134 TM Netherlands
  • Nijmegen 6525 GA Netherlands
  • Tilburg 5042 AD Netherlands
  • Bydgoszcz 85-165 Poland
  • Lodz 93-513 Poland
  • Lublin 20-362 Poland
  • Poznan 60-569 Poland
  • Rybnik 44-200 Poland
  • Siedlce 08-110 Poland
  • Waliszew 05-135 Poland
  • Warszawa 02-781 Poland
  • Wroclaw 50 - 556 Poland
  • Barnaul 656049 Russian Federation
  • Chelyabinsk 454048 Russian Federation
  • Chelyabinsk 454087 Russian Federation
  • Moscow 115478 Russian Federation
  • Moscow 119435 Russian Federation
  • Moscow 125284 Russian Federation
  • Novosibirsk 630099 Russian Federation
  • Omsk 644013 Russian Federation
  • St. Petersburg 191104 Russian Federation
  • St. Petersburg 194017 Russian Federation
  • St. Petersburg 197022 Russian Federation
  • St. Petersburg 197136 Russian Federation
  • Sabadell Barcelona 08208 Spain
  • Palma de Mallorca Illes Baleares 07120 Spain
  • Barcelona 08003 Spain
  • Barcelona 08025 Spain
  • Barcelona 08035 Spain
  • Barcelona 08036 Spain
  • Cáceres 10003 Spain
  • Córdoba 14004 Spain
  • Lugo 27004 Spain
  • Madrid 28007 Spain
  • Madrid 28034 Spain
  • Madrid 28041 Spain
  • Madrid 28046 Spain
  • Málaga 29010 Spain
  • Valencia 46009 Spain
  • Göteborg 413 45 Sweden
  • Lund 221 85 Sweden
  • Stockholm 118 83 Sweden
  • Stockholm 171 76 Sweden
  • Umeå 901 85 Sweden
  • Uppsala 751 85 Sweden
  • Kaohsiung 807 Taiwan
  • Kaohsiung 833 Taiwan
  • Taichung 40447 Taiwan
  • Taipei 10002 Taiwan
  • Taipei 11217 Taiwan
  • Taoyuan 333 Taiwan
  • Colchester Essex CO4 5JR United Kingdom
  • Romford Essex RM7 0AG United Kingdom
  • Middlesborough North Yorkshire TS4 3BW United Kingdom
  • Oxford Oxfordshire OX3 7LJ United Kingdom
  • Belfast BT9 7AB United Kingdom
  • Glasgow G12 0YN United Kingdom
  • London NW1 2PG United Kingdom
  • London SW3 6JJ United Kingdom
  • London W6 8RF United Kingdom

View trial on ClinicalTrials.gov


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