A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

PHASE3CompletedINTERVENTIONAL
Enrollment

921

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

July 31, 2011

Study Completion Date

February 28, 2014

Conditions
Hormone Refractory Prostate CancerBone Metastases
Interventions
DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.

DRUG

Placebo

Isotonic saline 6 IV administrations separated by 4 weeks intervals.

DRUG

Best standard of care (BSoC)

Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.

Trial Locations (134)

1340

Ottignies

2010

Sydney

2031

Randwick

2065

St Leonards

2076

Wahroonga

2170

Liverpool

2521

Wollongong

3065

Fitzroy

4029

Brisbane

4350

Toowoomba

5000

Adelaide

5011

Adelaide

5021

Bergen

6009

Nedlands

6026

Ålesund

7000

Hobart

7006

Trondheim

8092

Bodø

8500

Kortrijk

9038

Tromsø

10060

Candiolo

10967

Berlin

14004

Córdoba

14197

Berlin

15706

Santiago de Compostela

20162

Milan

20246

Hamburg

24128

Bergamo

25209

Montbéliard

28922

Alcorcón

30625

Hanover

31008

Pamplona

33612

Tampa

35043

Marburg

37099

Göttingen

42123

Reggio Emilia

44137

Dortmund

46026

Valencia

47014

Meldola

48903

Barakaldo

50009

Zaragoza

55131

Mainz

60590

Frankfurt am Main

63110

St Louis

65653

Brno

70112

New Orleans

80187

Sandviken

82606

Bratislava

83305

Bratislava

85925

La Roche-sur-Yon

89075

Ulm

89169

Las Vegas

92210

Saint-Cloud

95661

Roseville

97517

Banská Bystrica

258499

Singapore

308433

Singapore

4428164

Kfar Saba

6093000

Zrifin

6423906

Tel Aviv

8410101

Beersheba

14784400

Barretos

30380490

Belo Horizonte

90048-0750

Los Angeles

19111-2497

Philadelphia

41830-492

Salvador

30110-090

Belo Horizonte

20551 030

Rio de Janeiro

Unknown

Porto Alegre

Piracicaba

Chai Wan

Hong Kong

Kowloon

Cardiff

05403-900

São Paulo

T6G 1Z2

Edmonton

N6A 4G5

London

K1H 8L6

Ottawa

M4N 3M5

Toronto

430 12

Chomutov

775 20

Olomouc

708 52

Ostrava

305 99

Plzen - Bory

140 59

Prague

401 13

Ústí nad Labem

1815 JD

Alkmaar

6532 SZ

Nijmegen

3015 CE

Rotterdam

N-4604

Kristiansand

0450

Oslo

N-0310

Oslo

85-165

Bydgoszcz

44-101

Gliwice

25-734

Kielce

31-051

Krakow

20-954

Luiblin

02-781

Warsaw

50 - 556

Wroclaw

50-981

Wroclaw

03659

Martin

08181

Prešov

917 01

Trnava

08025

Barcelona

08035

Barcelona

08036

Barcelona

413 45

Gothenburg

551 85

Jönköping

391 85

Kalmar

205 02

Malmo

171 76

Stockholm

851 86

Sundsvall

901 85

Umeå

BS2 8ED

Bristol

RM7 0AG

Romford

LE1 5WW

Leicester

M20 4BX

Manchester

CH63 4JY

Bebington

NG5 1PB

Nottingham

TA1 5DA

Taunton

IP4 5PD

Ipswich

GU2 7XX

Guildford

SM2 5PT

Sutton

CV2 2DX

Coventry

B15 2TH

Birmingham

BT9 7AB

Belfast

BN2 5BD

Brighton

DE22 3NE

Derby

HU16 5JQ

Hull

LS9 7TF

Leeds

HA6 2RN

Northwood

PL6 8DH

Plymouth

S10 2SJ

Sheffield

SO16 6YD

Southampton

WV10 0QP

Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY