Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

696

Participants

Timeline

Start Date

November 9, 2020

Primary Completion Date

November 21, 2025

Study Completion Date

October 22, 2026

Conditions
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Interventions
DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection

DRUG

NAH therapy

Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone \[AAP\] or enzalutamide) by mouth (per os) daily

Trial Locations (118)

0

Hong Kong Integrated Oncology Centre (HKIOC), Central

Pamela Youde Nethersole Eastern Hospital, Chai Wan

704

National Cheng Kung University Hospital, Tainan City

1083

Semmelweis University, Budapest

1160

Klinik Ottakring - Wilhelminenspital, Vienna

1250

Baskent Universitesi Seyhan Hastanesi, Adana

2031

Prince of Wales Hospital NSW, Sydney

2065

Northern Cancer Institute, St Leonards

2154

Specialist Services Medical Group, Castle Hill

2250

Gosford Hospital, Gosford

2340

North West Cancer Centre, North Tamworth

2500

Illawarra Shoalhaven Local Health District, Wollongong

2747

Nepean Hospital, Kingswood

3080

Seoul National University Hospital, Seoul

4020

Kepler Universitätsklinikum Campus III, Linz

4101

Icon Cancer Care, Brisbane

4215

Tasman Health Care, Southport

4224

The Tweed Hospital, Tugun

5000

Royal Adelaide Hospital, Adelaide

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz, Szolnok

6050

Ankara Yildirim Beyazit Universitesi Tip Fakültesi, Ankara

6100

Ankara Universitesi Tip Fakultesi Hastanesi, Ankara

Hacettepe Universitesi Tip Fakultesi, Ankara

6189

Centre Antoine Lacassagne, Nice

6591

Seoul St. Mary's Hospital, Seoul

7120

Hospital Universitari Son Espases - Oncologia, Palma de Mallorca

10408

National Cancer Center, Goyang-si

11009

Hospital Universitario Puerta Del Mar - Oncologia, Cadiz

11217

Taipei Veterans General Hospital, Taipei

12002

Hospital General Universitario de Castellon - Oncologia, Castellon

12808

Všeobecná fakultní nemocnice v Praze, Prague

13273

Institut Paoli-Calmettes - Marseille, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre de Lutte Contre le Cancer François Baclesse, Caen

15009

Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro - Oncologia, A Coruña

15121

Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria_Presidio Civile - Oncologia, Alessandria

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

16128

Ente Ospedaliero Ospedali Galliera Di Genova - Oncologia Medica, Genoa

17007

I.C.O Girona, Girona

20141

Istituto Europeo di Oncologia s.r.l, Milan

21079

Centre Georges Francois Leclerc Dijon, Dijon

22030

Trakya Univ. Tip Fak., Edirne

23007

Hospital Universitario De Jaen - Oncologia, Jaén

27003

Hospital Universitario Lucus Augusti - Oncologia, Lugo

27070

Gaziantep Universitesi Tip Fakultesi, Gaziantep

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta De Hierro De Majadahonda - Oncologia, Majadahonda

29010

Hospital Universitario Virgen De La Victoria - Oncology, Málaga

29470

Hôpital Morvan - Brest, Brest

33000

Hôpital Saint André - Bordeaux, Bordeaux

33011

Hospital Central de Asturias, Oviedo

33079

Mersin Universitesi Tip Fakultesi, Mersin

33081

Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati, Aviano

33305

Chang Gung Memorial Hospital at Linkou, Taoyuan District

33520

Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS), Tampere

34093

Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul

34098

Istanbul Egitim ve Arastirma Hastanesi, Istanbul

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi, Istanbul

34722

TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has, Istanbul

34810

Medipol Universitesi Tip Fakultesi, Istanbul

35062

Centre Eugène Marquis - Rennes Cedex, Rennes

35100

Dokuz Eylul Universitesi Tip Fakultesi, Izmir

Ege Universitesi Tip Fakultesi, Izmir

35128

Istituto Oncologico Veneto_Padova - UOC Oncologia 1, Padua

35180

Izmir Tepecik Egitim ve Arastirma Hastanesi, Izmir

35575

Izmir Ekonomi Universitesi Medikal Point Hastanesi, Izmir

38039

Erciyes Universitesi Tip Fakultesi, Kayseri

38122

Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica, Trento

38700

Centre Hospitalier Universitaire - Grenoble, Grenoble

40705

Taichung Veterans General Hospital, Taichung

41124

Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia, Modena

43126

Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica, Parma

44124

University Hospital Of Ferrara - Oncologia Clinica, Ferrara

46009

Instituto Valenciano de Oncología, Valencia

48149

Universitätsklinikum Münster, Münster

51726

Institut de Cancerologie Jean Godinot, Reims

54519

Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandœuvre-lès-Nancy

55101

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

55139

Ondokuz Mayis Uni Tip Fakultesi, Samsun

60220

Seinäjoen keskussairaala, Seinäjoki

67200

CHU Strasbourg - Hopital Hautepierre, Strasbourg

90220

Oulun yliopistollinen sairaala, Oulu

94010

Hôpital Henri Mondor, Créteil

94805

Gustave Roussy - Departement Oncologie-Radiotherapie, Villejuif

168583

National Cancer Center Singapore - Oncology Department, Singapore

169608

Singapore General Hospital, Singapore

249036

National Medical Research Radiology Center, Obninsk

454087

Chelyabinsk Regional Oncology Dispensary, Chelyabinsk

807377

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

3436212

Lady Davis Carmel Medical Center, Haifa

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

656 91

Fakultni nemocnice u sv. Anny, Brno

430 12

Nemocnice Chomutov, o.z., Chomutov

460 63

Krajska Nemocnice Liberec, Liberec

120 00

Urocentrum Praha, s.r.o., Prague

140 59

Fakultni Thomayerova Nemocnice, Prague

180 81

Fakultní nemocnice Bulovka, Prague

00180

Docrates Klinikka, Helsinki

MISSING

Prince of Wales Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

TBC

Tuen Mun Hospital, TBC

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Servizio di Radioterapia Oncologica, Rome

LT-50009

The Hospital of Lithuanian University of Health SciencesLUHS, Kaunas

LT-92288

PI Klaipedos University Hospital, Klaipėda

LT-08660

National Cancer Institute, Vilnius

LT-08661

Vilnius University Hospital Santaros Klinikos, Vilnius

75-851

Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii, Koszalin

31-115

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Krakow

20-582

Scanmed SA ZOZ Gastromed, Lublin

04-073

Szpital Grochowski im. dr.med. Rafala Masztaka, Warsaw

50-556

Uniwersytecki Szpital Kliniczny UM we Wroclawiu, Wroclaw

05505

Asan Medical Center - Oncology Department, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08035

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

Unknown

"Hospital de la Santa Creu i Sant Pau , Gynecology Department"

"Marmara University Medical Faculty , Pediatric Nephrology"

"NHS Greater Glasgow & Clyde , Beatson West of Scotland Cancer Centre - Clinical Research Unit"

RG1 5AN

Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology, Reading

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY