1,306
Participants
Start Date
November 30, 2016
Primary Completion Date
October 25, 2021
Study Completion Date
April 11, 2023
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.
Taipei
Bruxelles - Brussel
Brussels
Bruxelles - Brussel
Sofia
Sofia
Sofia
Sydney
Randwick
Wilrijk
Vratsa
Fitzroy
Seoul
Adelaide
Namur
Kurralta Park
Gabrovo
Pleven
Charleroi
Seoul
Seoul
Palma de Mallorca
Barcelona
Ghent
Varna
Cáceres
New York
Prague
Turin
Taipei
Gyeonggi-do
Berlin
Poughkeepsie
Marseille
Seongnam-si
Córdoba
Buffalo
Rochester
Pittsburgh
Camp Hill
Stockholm
Rostock
Bala-Cynwyd
Milan
Turku
Towson
Baltimore
Fairfax
Charlottesville
Besançon
Lugo
Winston-Salem
Madrid
Madrid
Novara
Málaga
Brest
North Charleston
Charleston
Myrtle Beach
Greenville
Atlanta
Bordeaux
Taoyuan District
Boca Raton
Tampere
Montpellier
Padua
Saint-Grégoire
Verona
Trento
Braunschweig
Magdeburg
Bologna
Louisville
Taichung
Jyväskylä
Parma
Columbus
Cleveland
Saint-Herblain
Valencia
Busan
Münster
Detroit
Angers
Reims
Milwaukee
Nancy
Billings
Chicago
Gwangju
Cuernavaca
Clermont-Ferrand
Monterrey
Strasbourg
Pierre-Bénite
New Orleans
Kuopio
Tübingen
Nürtingen
Oklahoma City
Dallas
Querétaro City
Temple
Freiburg im Breisgau
Mazatlán
Salt Lake City
Chandler
Tucson
Poitiers
Albuquerque
Ulm
Oulu
Duarte
Erlangen
Créteil
Villejuif
Cergy-Pontoise
Everett
Beijing
Beijing
Beijing
Beijing
Beijing
Shenyang
Shengyang
Moscow
Moscow
Changchun
Saint Petersburg
Saint Petersburg
Saint Petersburg
Shanghai
Shanghai
Shanghai
Shanghai
Shanghai
Shanghai
Nanjing
Nanjing
Hefei City, Anhui Province
Jinan
Jinan
Yantai
Tianjin
Tianjin
Hangzhou
Hangzhou
Wenzhou
Nanchang
Xiamen
Chongqing
Changsha
Wuhan
Wuhan
Zhengzhou
Chelyabinsk
Chelyabinsk
Guangzhou
Novosibirsk
Omsk
Barnaul
Daegu
Xi'an
Kaohsiung City
Safed
Haifa
Petah Tikva
Holon
Tel Aviv
Zrifin
Beersheba
Jerusalem
Beverly Hills
Los Angeles
Stanford
Washington D.C.
Gainesville
Tampa
Peoria
Boston
Boston
Boston
Omaha
Lebanon
Camden
Englewood
Hackensack
The Bronx
Columbus
Kettering
Charleston
Richmond
Cachoeiro de Itapemirim
Salvador
Curitiba
Natal
Porto Alegre
Santo André
São Paulo
Rio de Janeiro
Rio de Janeiro
Calgary
Edmonton
Toronto
Toronto
Montreal
Shijiazhuang
Brno
Brno
Prague
Prague
Prague
Prague
Helsinki
Mikkeli
Jena
Rome
Nagoya
Hirosaki
Asahi
Kashiwa
Sakura
Matsuyama
Sapporo
Kobe
Kanazawa
Kanazawa
Kita
Yokohama
Yokohama
Tsu
Sendai
Kashihara
Sayama
Suita
Hamamatsu
Shimotsuke
Utsunomiya
Bunkyo-ku
Bunkyo-ku
Bunkyo-ku
Koto-ku
Meguro-ku
Minato-ku
Mitaka
Nakano-ku
Shinjuku-ku
Shinjuku-ku
Yonago
Ube
Chiba
Chiba
Fukuoka
Gifu
Kumamoto
Miyazaki
Nagasaki
Okayama
Osaka
Osaka
Tokushima
Wakayama
Mexico City
México, D. F.
Amsterdam
Amsterdam
Dordrecht
Geleen
Hilversum
Hoofddorp
The Hague
Tilburg
Lodz
Lublin
Rybnik
Siedlce
Waliszew
Warsaw
Seoul
Seoul
Seoul
Seoul
Sabadell
Barcelona
Barcelona
Barcelona
Gothenburg
Lund
Umeå
Uppsala
Colchester
Romford
Middlesbrough
Belfast
Glasgow
London
London
London
Lead Sponsor
Orion Corporation, Orion Pharma
INDUSTRY
Bayer
INDUSTRY