Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,509

Participants

Timeline

Start Date

September 12, 2014

Primary Completion Date

September 3, 2018

Study Completion Date

June 14, 2021

Conditions
Prostate Cancer Non-MetastaticCastration-Resistant
Interventions
DRUG

Darolutamide (Nubeqa, BAY1841788)

Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

DRUG

Placebo

Matching placebo 2 tablets twice daily with food.

Trial Locations (404)

100

Taipei

807

Kaohsiung City

1020

Vienna

1086

Budapest

1090

Vienna

1145

Budapest

1204

Budapest

1680

Sofia

2031

Randwick

2065

St Leonards

2660

Kyiv

2820

Bonheiden

3065

Fitzroy

3800

Sint-Truiden

4000

Liège

4001

La Victoria

4032

Debrecen

4101

South Brisbane

4400

Nyíregyháza

4814

Douglas

5000

Szolnok

5037

Kurralta Park

6045

Port Elizabeth

6530

George

6725

Szeged

6800

Libramont

7100

Szekszárd

7505

Cape Town

7646

Paarl

7700

Rondebosch

7925

Cape Town

8500

Kortrijk

8900

Zalaegerszeg

9000

Varna

9023

Győr

10043

Turin

10060

Turin

10461

The Bronx

10469

The Bronx

11000

Belgrade

11009

Cadiz

11080

Belgrade

11407

Jerez de la Frontera

12203

Berlin

13210

Syracuse

13419

Tallinn

14004

Córdoba

14076

Caen

15036

San Isidro

15046

Lima

15073

Lima

18000

Niš

18012

Granada

19004

Bala-Cynwyd

19230

Hagenow

20246

Hamburg

21000

Dijon

21204

Baltimore

21401

Annapolis

21565

Incheon

21801

Salisbury

22031

Fairfax

22081

Hamburg

22328

Bucharest

23235

Richmond

23462

Virginia Beach

25030

Besançon

26003

Wheeling

27003

Lugo

27203

Asheboro

28007

Madrid

28040

Madrid

28041

Madrid

28046

Madrid

28277

Charlotte

28644

Cheongju-si

28922

Alcorcón

29010

Málaga

29572

Myrtle Beach

32803

Orlando

33076

Bordeaux

33305

Taoyuan District

33486

Boca Raton

33521

Tampere

34295

Montpellier

34298

Montpellier

34724

Istanbul

34952

Port Saint Lucie

35033

Rennes

35039

Marburg

35100

Izmir

35152

Haifa

35209

Homewood

35340

Izmir

37007

Salamanca

37044

Tours

37209

Nashville

37412

Herzberg am Harz

37603

Holzminden

39120

Magdeburg

40225

Düsseldorf

40705

Taichung

41009

Seville

41013

Seville

41124

Modena

41345

Bucharest

41404

Daegu

42103

Wuppertal

42601

Daegu

43126

Parma

43230

Gahanna

44093

Nantes

44130

Middleburg Heights

44195

Cleveland

44718

Canton

45030

Manisa

45212

Cincinnati

45468

Mülheim

46009

Valencia

46015

Valencia

46026

Valencia

46143

Greenwood

46202

Indianapolis

47014

Forlì Cesena

47130

Jeffersonville

48013

Bilbao

48073

Royal Oak

48149

Münster

49100

Angers

49102

Dnipro

49546

Grand Rapids

50048

Kryvyi Rih

50266

West Des Moines

50659

Bucharest

50937

Cologne

51726

Reims

52100

Arezzo

54100

Nancy

55131

Mainz

58002

Chernivtsi

58140

Sivas

60220

Seinäjoki

60590

Frankfurt am Main

60612

Chicago

61037

Kharkiv

61469

Gwangju

62702

Springfield

63011

Clermont-Ferrand

64100

Bayonne

66100

Chieti

67000

Strasbourg

67226

Wichita

68114

Omaha

68130

Omaha

69495

Pierre-Bénite

69600

Zaporizhzhya

70121

New Orleans

70210

Kuopio

72076

Tübingen

72622

Nürtingen

72764

Reutlingen

73100

Lecce

73104

Oklahoma City

73230

Kirchheim unter Teck

75000

Bucharest

75010

Paris

75014

Paris

75231

Dallas

75417

Mühlacker

76031

Rouen

79312

Emmendingen

80131

Napoli

80134

Parker

80211

Denver

80220

Denver

81362

Kaoshiung

83814

Coeur d'Alene

85704

Tucson

85925

La Roche-sur-Yon

86021

Poitiers

87042

Limoges

88014

Uzhhorod

88100

Catanzaro

90048

Los Angeles

90127

Palermo

90513

Zirndorf

90603

Whittier

91101

Trenčín

92093

La Jolla

92120

San Diego

92151

Suresnes

92653

Laguna Hills

92708

Fountain Valley

94010

Créteil

94160

Saint-Mandé

94805

Villejuif

95303

Cergy-Pontoise

98125

Messina

99503

Anchorage

100337

Ploieşti

105425

Moscow

117997

Moscow

125284

Moscow

129301

Moscow

153040

Ivanovo

191014

Saint Petersburg

194017

Saint Petersburg

194354

Saint Petersburg

197022

Saint Petersburg

200347

Craiova

200385

Craiova

220013

Minsk

223040

Lesnoy

230002

Montería

249036

Obninsk

344022

Rostov-on-Don

357502

Pyatigorsk

400015

Cluj-Napoca

410054

Saratov

410159

Oradea

420029

Kazan'

450008

Ufa

454087

Chelyabinsk

460021

Orenburg

540103

Târgu Mureş

600009

Vladimir

603006

Nizhny Novgorod

625041

Tyumen

630099

Novosibirsk

644013

Omsk

660133

Krasnoyarsk

681004

Floridablanca

90073-1003

Los Angeles

60201-1613

Evanston

02114

Boston

03756-1000

Lebanon

08043

Voorhees Township

C1120AAT

Buenos Aires

S3000FFV

Santa Fé

T4000HXU

San Miguel de Tucumán

X5000HXL

Córdoba

X5004FHP

Córdoba

X5016KEH

Córdoba

F5300COE

La Rioja

60430-230

Fortaleza

40050-001

Salvador

74605-070

Goiânia

30150-320

Belo Horizonte

36010-510

Juiz de Fora

38408-150

Uberlândia

81520-060

Curitiba

50070-550

Recife

99010-080

Passo Fundo

90050 170

Porto Alegre

90610-000

Porto Alegre

88301-220

Itajaí

14784-400

Barretos

17210-080

Jaú

14048-900

Ribeirao Preto - SP

01209-000

São Paulo

01236-030

São Paulo

01246-000

São Paulo

04014-002

São Paulo

04039-004

São Paulo

18035-300

Sorocaba

T2V 1P9

Calgary

B3H 2Y9

Halifax

L7N 3V2

Burlington

L8N 4A6

Hamilton

K7L 3J7

Kingston

N6A 5W9

London

M4N 3M5

Toronto

M5G 2M9

Toronto

J2G 8Z9

Granby

H9R 4S3

Pointe-Claire

050034

Medellín

466 60

Jablonec nad Nisou

280 00

Kolín

775 20

Olomouc

746 01

Opava

120 00

Prague

128 08

Prague

160 00

Prague

180 81

Prague

00290

Helsinki

FIN-20521

Turku

01307

Dresden

00144

Rome

00189

Rome

466-8560

Nagoya

277-8577

Kashiwa

839-0863

Kurume

963-8052

Kōriyama

371-8511

Maebashi

739-0696

Ōtake

060-8543

Sapporo

650-0047

Kobe

311-3193

Higashiibaraki

920-8530

Kanazawa

252-0375

Sagamihara

232-0024

Yokohama

238-8558

Yokosuka

981-8563

Sendai

386-8610

Ueda

634-8522

Kashihara

879-5593

Yufu

589-8511

Sayama

351-0102

Wako

431-3192

Hamamatsu

321-0974

Utsunomiya

113-8431

Bunkyo-ku

113-8603

Bunkyo-ku

173-0015

Itabashi-ku

105-8471

Minato-ku

181-8611

Mitaka

164-8541

Nakano-ku

160-8582

Shinjuku-ku

130-8587

Sumida-ku

755-8505

Ube

260-8717

Chiba

910-8526

Fukui

730-8518

Hiroshima

602-8566

Kyoto

852-8501

Nagasaki

852-8511

Nagasaki

700-8558

Okayama

541-8567

Osaka

545-8586

Osaka

558-8558

Osaka

930-0194

Toyama

LV5401

Daugavpils

LV-3001

Jelgava

LV-3401

Leipaja

LV-1001

Riga

LV-1002

Riga

LV-1038

Riga

LT-45434

Kaunas

LT-50009

Kaunas

LT-92288

Klaipėda

LT-08660

Vilnius

LT-08661

Vilnius

82-300

Elblag

80-952

Gdansk

90-302

Lodz

20-718

Lublin

05-400

Otwock

35-021

Rzeszów

08-110

Siedlce

02-616

Warsaw

02-781

Warsaw

04-125

Warsaw

54-144

Wroclaw

4835-044

Guimarães

2801-951

Almada

4464-513

Matosinhos Municipality

4710-243

Braga

1099-023

Lisbon

1150-199

Lisbon

1400-038

Lisbon

1500-650

Lisbon

4200-072

Porto

4200-319

Porto

851 01

Bratislava

851 05

Bratislava

036 59

Martin

0002

Pretoria

0083

Pretoria

03080

Seoul

06273

Seoul

03722

Seoul

05505

Seoul

06351

Seoul

06591

Seoul

03203

Elche

08907

L'Hospitalet de Llobregat

08208

Sabadell

08221

Terrassa

07500

Manacor

07120

Palma de Mallorca

08035

Barcelona

08036

Barcelona

413 45

Gothenburg

701 85

Örebro

171 76

Stockholm

751 85

Uppsala

06500

Ankara

04053

Kyiv

RG1 5AN

Reading

SA14 8QF

Llanelli

RM7 0AG

Romford

SG1 4AB

Stevenage

DA2 8DA

Dartford

ME16 9QQ

Maidstone

PR2 4HT

Preston

CH63 4JY

Bebington

DN15 7BH

Scunthorpe

BA1 3NG

Bath

ST4 6QG

Stoke-on-Trent

DY1 2HQ

Dudley

HD3 3EA

Huddersfield

WF1 4DG

Wakefield

CF14 4XN

Cardiff

G12 0YN

Glasgow

SW17 0QT

London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

Bayer

INDUSTRY