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

Last updated: January 30, 2025
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Radium-223 dichloride (Xofigo, BAY88-8223)

Abiraterone

Prednisone/Prednisolone

Clinical Study ID

NCT02043678
15396
2013-003438-33
  • Ages > 18
  • Male

Study Summary

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate

  • Male subjects of age ≥ 18 years

  • Prostate cancer progression documented by prostate specific antigen (PSA) accordingto the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progressionaccording to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

  • Two or more bone metastases on bone scan within 4 weeks prior to randomization withno lung, liver, other visceral and/or brain metastasis

  • Asymptomatic or mildly symptomatic prostate cancer

  • Subjects who received combined androgen blockade with an anti-androgen must haveshown PSA progression after discontinuing the anti-androgen prior to enrollment

  • Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)

  • Eastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1

Exclusion

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes,mitoxantrone and estramustine

  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mgprednisone/prednisolone twice daily

  • Pathological finding consistent with small cell carcinoma of the prostate

  • History of visceral metastasis, or presence of visceral metastasis detected byscreening imaging examinations

  • History of or known brain metastasis

  • Malignant lymphadenopathy exceeding 3 cm in short-axis diameter

  • Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screeningand during the whole screening period before randomization

  • Imminent spinal cord compression based on clinical findings and/or magneticresonance imaging (MRI). Subjects with history of spinal cord compression shouldhave completely recovered

  • Use of opiate analgesics for cancer-related pain, including codeine anddextropropoxyphene, currently or anytime during the 4- week period prior torandomization.

Study Design

Total Participants: 806
Treatment Group(s): 4
Primary Treatment: Radium-223 dichloride (Xofigo, BAY88-8223)
Phase: 3
Study Start date:
March 30, 2014
Estimated Completion Date:
February 08, 2024

Study Description

This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.

Connect with a study center

  • St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Adelaide, South Australia 5000
    Australia

    Site Not Available

  • East Bentleigh, Victoria 3165
    Australia

    Site Not Available

  • Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • St Vincents Hospital

    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • Melbourne, Victoria 3065
    Australia

    Site Not Available

  • St Vincents Hospital Sydney

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Darlinghurst, 2010
    Australia

    Site Not Available

  • East Melbourne, 3002
    Australia

    Site Not Available

  • Hollywood Private Hospital

    Nedlands, 6009
    Australia

    Site Not Available

  • Randwick, 2031
    Australia

    Site Not Available

  • empty

    Anderlecht, 1070
    Belgium

    Site Not Available

  • Anderlecht, 1070
    Belgium

    Site Not Available

  • Bruxelles, 1070
    Belgium

    Site Not Available

  • Bruxelles - Brussel, 1200
    Belgium

    Site Not Available

  • Edegem, 2650
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Belo Horizonte, Minas Gerais 30130-090
    Brazil

    Site Not Available

  • Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, Sao Paulo 14784400
    Brazil

    Site Not Available

  • Barretos/SP, Sao Paulo 14784-400
    Brazil

    Site Not Available

  • São Paulo, Sao Paulo 01246-000
    Brazil

    Site Not Available

  • Hospital Sirio Libanes

    Sao Paulo, 01308-050
    Brazil

    Site Not Available

  • Sao Paulo, 01409-000
    Brazil

    Site Not Available

  • Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • Québec, Quebec G1R 2J6
    Canada

    Site Not Available

  • CHUQ-Hopital Hotel-Dieu de Quebec

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • empty

    HUS, 00029
    Finland

    Site Not Available

  • Helsinki, FIN-00260
    Finland

    Site Not Available

  • Kuopio, FIN- 70029
    Finland

    Site Not Available

  • Seinäjoki, 60220
    Finland

    Site Not Available

  • Tampere, 33520
    Finland

    Site Not Available

  • Besancon, 25030
    France

    Site Not Available

  • Bordeaux Cedex, 33076
    France

    Site Not Available

  • Centre François Baclesse - CLCC - Caen

    Caen, 14073
    France

    Site Not Available

  • empty

    Grenoble, 38043
    France

    Site Not Available

  • Centre Hospitalier Universitaire - Grenoble

    La Tronche, 38700
    France

    Site Not Available

  • Centre Oscar Lambret - Lille

    Lille Cedex, 59020
    France

    Site Not Available

  • POITIERS cedex, 86021
    France

    Site Not Available

  • Paris, 75010
    France

    Site Not Available

  • Hôpital Saint Louis - Paris

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Poitiers, 86021
    France

    Site Not Available

  • empty

    Poitiers Cedex, 86021
    France

    Site Not Available

  • empty

    Saint Herblain, 44805
    France

    Site Not Available

  • Saint-Herblain, 44800
    France

    Site Not Available

  • empty

    Toulouse, 31052
    France

    Site Not Available

  • Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Ulm, Baden-Württemberg 89075
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • München, Bayern 81675
    Germany

    Site Not Available

  • Marburg, Hessen 35033
    Germany

    Site Not Available

  • Kliniken der Medizinischen Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitätsklinikum Aachen

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Site Not Available

  • Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Johannes-Gutenberg-Universität Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Dresden, Sachsen 1307
    Germany

    Site Not Available

  • Jena, Thüringen 7747
    Germany

    Site Not Available

  • Berlin, 12203
    Germany

    Site Not Available

  • Urologische Gemeinschaftspraxis

    Bremen, 28277
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    Hamburg, 20246
    Germany

    Site Not Available

  • Afula, 1834111
    Israel

    Site Not Available

  • Beer Sheva, 8410101
    Israel

    Site Not Available

  • Haifa, 3109601
    Israel

    Site Not Available

  • Jerusalem, 9112001
    Israel

    Site Not Available

  • Kfar Saba, 4428164
    Israel

    Site Not Available

  • Petach Tikva, 4941492
    Israel

    Site Not Available

  • empty

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Ramat Gan, 5262000
    Israel

    Site Not Available

  • Tel Aviv, 6423906
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Tel Hashomer, 5262000
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Zerifin, 6093000
    Israel

    Site Not Available

  • Zerifin, 7030000
    Israel

    Site Not Available

  • empty

    Zrifin, 7030000
    Israel

    Site Not Available

  • Zrifin, 7030000
    Israel

    Site Not Available

  • Modena, Emilia-Romagna 41100
    Italy

    Site Not Available

  • Roma, Lazio 189
    Italy

    Site Not Available

  • Genova, Liguria 16128
    Italy

    Site Not Available

  • Milano, Lombardia 20141
    Italy

    Site Not Available

  • Cagliari, Sardegna 9125
    Italy

    Site Not Available

  • empty

    Arezzo, Toscana 52100
    Italy

    Site Not Available

  • Arezzo, Toscana 52100
    Italy

    Site Not Available

  • Cortona, Toscana 52040
    Italy

    Site Not Available

  • Trento, Trentino-Alto Adige 38100
    Italy

    Site Not Available

  • A.O.U. Policlinico Consorziale

    Bari, 70124
    Italy

    Site Not Available

  • A.O.U. di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • A.O. Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • ASP Palermo - Sicilia

    Palermo, 90146
    Italy

    Site Not Available

  • Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • Hirosaki, Aomori 036-8563
    Japan

    Site Not Available

  • Chiba-shi, Chiba 260-8677
    Japan

    Site Not Available

  • Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Matsuyama, Ehime 791-0280
    Japan

    Site Not Available

  • Sapporo, Hokkaido 003-0804
    Japan

    Site Not Available

  • Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Tsukuba, Ibaraki 305-8576
    Japan

    Site Not Available

  • Kanazawa, Ishikawa 920-8641
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita, Kagawa 761-0793
    Japan

    Site Not Available

  • Kita, Kagawa 761-0793
    Japan

    Site Not Available

  • Kita-gun, Kagawa 761-0793
    Japan

    Site Not Available

  • Yokohama, Kanagawa 241-8515
    Japan

    Site Not Available

  • Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Kurashiki, Okayama 701-0192
    Japan

    Site Not Available

  • Okayama-city, Okayama 700-8558
    Japan

    Site Not Available

  • Kinki University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • Sayama, Osaka 589-8511
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Hamamatsu, Shizuoka 431-3192
    Japan

    Site Not Available

  • Bunkyo-Ku, Tokyo 113-0022
    Japan

    Site Not Available

  • Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Koto-ku, Tokyo 135-8550
    Japan

    Site Not Available

  • Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Ube, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Chiba, 260-8717
    Japan

    Site Not Available

  • Fukuoka, 812-8582
    Japan

    Site Not Available

  • Kumamoto, 860-0008
    Japan

    Site Not Available

  • Miyazaki, 889-1692
    Japan

    Site Not Available

  • Nagasaki, 852-8501
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Okayama, 700-8558
    Japan

    Site Not Available

  • Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Bodø, 8092
    Norway

    Site Not Available

  • Lørenskog, 1478
    Norway

    Site Not Available

  • Oslo, 450
    Norway

    Site Not Available

  • Gdansk, 80-214
    Poland

    Site Not Available

  • Gdynia, 81-519
    Poland

    Site Not Available

  • Gliwice, 44-101
    Poland

    Site Not Available

  • Poznan, 61-485
    Poland

    Site Not Available

  • Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

    Warszawa, 02-781
    Poland

    Site Not Available

  • Moscow, 115478
    Russian Federation

    Site Not Available

  • Obninsk, 249036
    Russian Federation

    Site Not Available

  • Singapore, 258499
    Singapore

    Site Not Available

  • Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Badalona, Barcelona 8916
    Spain

    Site Not Available

  • empty

    Badalona (Barcelona), Barcelona 08916
    Spain

    Site Not Available

  • Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Malaga, Málaga 29010
    Spain

    Site Not Available

  • Barcelona, 08035
    Spain

    Site Not Available

  • Madrid, 28046
    Spain

    Site Not Available

  • empty

    Málaga, 29010
    Spain

    Site Not Available

  • Málaga, 29010
    Spain

    Site Not Available

  • Pamplona, 31008
    Spain

    Site Not Available

  • Sevilla, 41071
    Spain

    Site Not Available

  • Linköping, 581 85
    Sweden

    Site Not Available

  • Skånes Universitetssjukhus

    Lund, 221 85
    Sweden

    Site Not Available

  • Stockholm, 171 76
    Sweden

    Site Not Available

  • Sundsvall, 851 86
    Sweden

    Site Not Available

  • Sundsvalls Sjukhus

    Sundsvalls, 851 86
    Sweden

    Site Not Available

  • Umea, 901 85
    Sweden

    Site Not Available

  • Norrlands Universitetssjukhus, Umeå

    Umeå, 901 85
    Sweden

    Site Not Available

  • Umeå, 901 85
    Sweden

    Site Not Available

  • Växjö, 351 85
    Sweden

    Site Not Available

  • Edinburgh, Lothian EH4 2XU
    United Kingdom

    Site Not Available

  • Bebington, Merseyside CH63 4JY
    United Kingdom

    Site Not Available

  • Northwood, Middlesex HA6 2VR
    United Kingdom

    Site Not Available

  • empty

    Sheffield, South Yorkshire S10 2SJ
    United Kingdom

    Site Not Available

  • Guildford, Surrey GU2 7XX
    United Kingdom

    Site Not Available

  • Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne, Tyne And Wear NE4 6BE
    United Kingdom

    Site Not Available

  • Coventry, West Midlands CV2 2DX
    United Kingdom

    Site Not Available

  • Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • London, NW3 2QG
    United Kingdom

    Site Not Available

  • Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-7201
    United States

    Site Not Available

  • empty

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Anchorage, Alaska 99503
    United States

    Site Not Available

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Tucson, Arizona 85718
    United States

    Site Not Available

  • MemorialCare Health System

    Long Beach, California 90806
    United States

    Site Not Available

  • empty

    Los Angeles, California 90095
    United States

    Site Not Available

  • Oceanside, California 92056
    United States

    Site Not Available

  • empty

    San Diego, California 92123
    United States

    Site Not Available

  • empty

    Torrance, California 90505
    United States

    Site Not Available

  • Denver, Colorado 80211
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Care Health System

    Newark, Delaware 19713
    United States

    Site Not Available

  • Washington, District of Columbia 20007-2113
    United States

    Site Not Available

  • empty

    Washington, D.C., District of Columbia 20007-2197
    United States

    Site Not Available

  • empty

    Aventura, Florida 33180
    United States

    Site Not Available

  • Fort Myers, Florida 33901
    United States

    Site Not Available

  • University of Miami Hospital & Clinics

    Miami, Florida 33136
    United States

    Site Not Available

  • Atlanta, Georgia 30322
    United States

    Site Not Available

  • empty

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • empty

    Meridian, Idaho 83642
    United States

    Site Not Available

  • empty

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Indiana University Health Goshen Hospital

    Goshen, Indiana 46526
    United States

    Site Not Available

  • Jeffersonville, Indiana 47130
    United States

    Site Not Available

  • New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Biomedical Research Foundation of Northwest Louisiana

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Baltimore, Maryland 21201
    United States

    Site Not Available

  • Walter Reed National Military Medical Center

    Bethesda, Maryland 20889-5600
    United States

    Site Not Available

  • Rockville, Maryland 20850
    United States

    Site Not Available

  • Towson, Maryland 21204
    United States

    Site Not Available

  • Boston, Massachusetts 02114-2696
    United States

    Site Not Available

  • Burlington, Massachusetts 1805
    United States

    Site Not Available

  • empty

    Lowell, Massachusetts 01854
    United States

    Site Not Available

  • Detroit, Michigan 48202
    United States

    Site Not Available

  • Traverse City, Michigan 49684
    United States

    Site Not Available

  • empty

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • empty

    West Bloomfield Township, Michigan 48322
    United States

    Site Not Available

  • Saint Louis, Missouri 63110
    United States

    Site Not Available

  • empty

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Omaha, Nebraska 68130
    United States

    Site Not Available

  • Las Vegas, Nevada 89169
    United States

    Site Not Available

  • empty

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • empty

    Edison, New Jersey 08837
    United States

    Site Not Available

  • Hackensack, New Jersey 7601
    United States

    Site Not Available

  • empty

    New York, New York 10032
    United States

    Site Not Available

  • Poughkeepsie, New York 12601
    United States

    Site Not Available

  • empty

    Rochester, New York 14642
    United States

    Site Not Available

  • Syracuse, New York 13210
    United States

    Site Not Available

  • Cancer Centers of North Carolina

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • empty

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • empty

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • empty

    Springfield, Oregon 97477
    United States

    Site Not Available

  • empty

    Bala Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15215
    United States

    Site Not Available

  • 21st Century Oncology

    Myrtle Beach, South Carolina 29577
    United States

    Site Not Available

  • empty

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Baylor Charles A. Sammons Cancer Center at Dallas

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology-Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • empty

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • empty

    Falls Church, Virginia 22031
    United States

    Site Not Available

  • Norfolk, Virginia 23502
    United States

    Site Not Available

  • empty

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

  • Seattle, Washington 98109-1023
    United States

    Site Not Available

  • Spokane, Washington 99208-1129
    United States

    Site Not Available

  • Wheeling, West Virginia 26003
    United States

    Site Not Available

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