NCT02043678 - Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms | Biotech Hunter

Enrollment

806

Participants

Timeline

Start Date

March 30, 2014

Primary Completion Date

February 15, 2018

Study Completion Date

February 8, 2024

Conditions

Prostatic Neoplasms

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles

DRUG

Matching placebo (normal saline)

Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles

DRUG

Abiraterone

1000 mg once daily, oral, with best supportive care

DRUG

Prednisone/Prednisolone

5 mg twice daily, oral, with best supportive care

Trial Locations (163)

152

Rome

189

Rome

450

Oslo

1070

Brussels

1200

Bruxelles - Brussel

1307

Dresden

1478

Lørenskog

1805

Burlington

2010

Sydney

2031

Randwick

2065

St Leonards

2650

Edegem

3002

East Melbourne

3065

Fitzroy

3084

Heidelberg

3165

East Bentleigh

5000

Adelaide

7601

Hackensack

7747

Jena

8036

Barcelona

8092

Bodø

8916

Badalona

9000

Ghent

9125

Cagliari

12203

Berlin

12601

Poughkeepsie

13210

Syracuse

15215

Pittsburgh

15240

Pittsburgh

16128

Genoa

19004

Bala-Cynwyd

20133

Milan

20141

Milan

20850

Rockville

21201

Baltimore

21204

Towson

23502

Norfolk

25030

Besançon

26003

Wheeling

28009

Madrid

28033

Madrid

28034

Madrid

28046

Madrid

28050

Madrid

29010

Málaga

30322

Atlanta

31008

Pamplona

31059

Toulouse

33011

Oviedo

33076

Bordeaux

33520

Tampere

33901

Fort Myers

35033

Marburg

38100

Trento

41071

Seville

41100

Modena

44800

Saint-Herblain

47130

Jeffersonville

48149

Münster

48202

Detroit

49684

Traverse City

52040

Cortona

60220

Seinäjoki

63110

St Louis

68130

Omaha

70112

New Orleans

75005

Paris

75010

Paris

80211

Denver

81675

München

85718

Tucson

86021

Poitiers

89075

Ulm

89169

Las Vegas

92056

Oceanside

99503

Anchorage

115478

Moscow

119074

Singapore

168583

Singapore

249036

Obninsk

258499

Singapore

1834111

Afula

3109601

Haifa

4428164

Kfar Saba

4941492

Petah Tikva

5262000

Ramat Gan

6423906

Tel Aviv

7030000

Ẕerifin

8410101

Beersheba

9112001

Jerusalem

20007-2113

Washington D.C.

02114-2696

Boston

98109-1023

Seattle

99208-1129

Spokane

30130-090

Belo Horizonte

90020-090

Porto Alegre

14784-400

Barretos/SP

01246-000

São Paulo

01409-000

São Paulo

T2N 4N2

Calgary

V5Z 4E6

Vancouver

R3A 1R9

Winnipeg

L8V 5C2

Hamilton

K1H 8L6

Ottawa

M4N 3M5

Toronto

H2L 4M1

Montreal

G1R 2J6

Québec

FIN-00260

Helsinki

FIN- 70029

Kuopio

466-8560

Nagoya

036-8563

Hirosaki

260-8677

Chiba

277-8577

Kashiwa

791-0280

Matsuyama

003-0804

Sapporo

650-0047

Kobe

305-8576

Tsukuba

920-8641

Kanazawa

761-0793

Kita-gun

236-0004

Yokohama

241-8515

Yokohama

980-8574

Sendai

390-8621

Matsumoto

701-0192

Kurashiki

700-8558

Okayama

589-8511

Sayama

431-3192

Hamamatsu

113-0022

Bunkyo-Ku

113-8431

Bunkyo-ku

135-8550

Koto-ku

160-8582

Shinjuku-ku

755-8505

Ube

260-8717

Chiba

811-1395

Fukuoka

812-8582

Fukuoka

860-0008

Kumamoto

889-1692

Miyazaki

852-8501

Nagasaki

1105 AZ

Amsterdam

6525 GA

Nijmegen

8025 AB

Zwolle

80-214

Gdansk

81-519

Gdynia

44-101

Gliwice

61-485

Poznan

08907

L'Hospitalet de Llobregat

08035

Barcelona

581 85

Linköping

171 76

Stockholm

851 86

Sundsvall

901 85

Umeå

351 85

Vaxjo

EH4 2XU

Edinburgh

CH63 4JY

Bebington

HA6 2VR

Northwood

GU2 7XX

Guildford

SM2 5PT

Sutton

NE4 6BE

Newcastle upon Tyne

CV2 2DX

Coventry

BT9 7AB

Belfast

LS9 7TF

Leeds

NW3 2QG

London

RM7 0AG

Romford