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

Last updated: April 27, 2016
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT00699751
15245
2007-006195-11
BC1-06
  • Ages > 18
  • Male

Study Summary

ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Known hormone refractory disease

  • Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy

  • No intention to use cytotoxic chemotherapy within the next 6 months

  • Either regular (not occasional) analgesic medication use for cancer related bone painor treatment with EBRT (External Beam Radiation Therapy) for bone pain

Exclusion

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during thetreatment period

  • Eligible for first course of docetaxel, i.e. patients who are fit enough, willing andwhere docetaxel is available

  • Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during thetreatment period, or failure to recover from adverse events due to cytotoxicchemotherapy administered more than 4 weeks ago

  • Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 forthe treatment of bony metastases within previous 24 weeks

  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer orlow-grade superficial bladder cancer)

  • History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvicCT or chest x-ray within previous 8 weeks

Study Design

Total Participants: 921
Study Start date:
June 01, 2008
Estimated Completion Date:
February 28, 2014

Study Description

The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).

Patients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3 years after first study drug administration.

Within the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals.

All patients received BSoC (Best Standard of Care).

This study has the original PCD as 14 October 2010, when a total of 316 deaths had been observed; this resulted in the Independent Data Monitoring Committee's (IDMC's) recommendation to stop the study as the primary efficacy analysis of overall survival had crossed the pre-specified boundary for efficacy. Later an updated analysis of primary endpoint in the first addendum was done with cut-off of 15 July 2011.

Connect with a study center

  • Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Randwick, New South Wales 2031
    Australia

    Site Not Available

  • St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Sydney, New South Wales 2010
    Australia

    Site Not Available

  • Wahroonga, New South Wales 2076
    Australia

    Site Not Available

  • Wollongong, New South Wales 2521
    Australia

    Site Not Available

  • Brisbane, Queensland 4029
    Australia

    Site Not Available

  • Toowoomba, Queensland 4350
    Australia

    Site Not Available

  • Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • St Vincent's Hspital

    Melbourne, Victoria
    Australia

    Site Not Available

  • Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Perth, Western Australia
    Australia

    Site Not Available

  • Kortrijk, 8500
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liège

    Liège,
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liège

    Liège,
    Belgium

    Site Not Available

  • Ottignies, 1340
    Belgium

    Site Not Available

  • Salvador, Bahia 41830-492
    Brazil

    Site Not Available

  • Belo Horizonte, Minas Gerais 30110-090
    Brazil

    Site Not Available

  • Porto Alegre, Rio Grande do Sul
    Brazil

    Site Not Available

  • Barretos, Sao Paulo 14784400
    Brazil

    Site Not Available

  • Piracicaba, Sao Paulo
    Brazil

    Site Not Available

  • Rio de Janeiro, 20551 030
    Brazil

    Site Not Available

  • Sao Paulo, 05403-900
    Brazil

    Site Not Available

  • Hc-Fmusp

    São Paulo,
    Brazil

    Site Not Available

  • HC-FMUSP

    São Paulo,
    Brazil

    Site Not Available

  • Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • London, Ontario N6A 4G5
    Canada

    Site Not Available

  • Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Brno, 65653
    Czech Republic

    Site Not Available

  • Chomutov, 430 12
    Czech Republic

    Site Not Available

  • Olomouc, 775 20
    Czech Republic

    Site Not Available

  • Ostrava, 708 52
    Czech Republic

    Site Not Available

  • Hospital Pardubice

    Pardubice,
    Czech Republic

    Site Not Available

  • empty

    Plzen, 305 99
    Czech Republic

    Site Not Available

  • Plzen - Bory, 305 99
    Czech Republic

    Site Not Available

  • Thomayer faculty hospital

    Praha,
    Czech Republic

    Site Not Available

  • Praha 4, 140 59
    Czech Republic

    Site Not Available

  • Usti nad Labem, 401 13
    Czech Republic

    Site Not Available

  • Centre Georges François LECLERC

    Dijon,
    France

    Site Not Available

  • La Roche Sur Yon, 85925
    France

    Site Not Available

  • Montbeliard, 25209
    France

    Site Not Available

  • Saint Cloud, 92210
    France

    Site Not Available

  • CRLCC René Gauducheau

    Saint Herblain,
    France

    Site Not Available

  • Centre René huguenin

    St Cloud,
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse,
    France

    Site Not Available

  • Ulm, Baden-Württemberg 89075
    Germany

    Site Not Available

  • Frankfurt, Hessen 60590
    Germany

    Site Not Available

  • Marburg, Hessen 35043
    Germany

    Site Not Available

  • Göttingen, Niedersachsen 37099
    Germany

    Site Not Available

  • Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Dortmund, Nordrhein-Westfalen 44137
    Germany

    Site Not Available

  • Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Berlin, 10967
    Germany

    Site Not Available

  • Universitätsklinikum Göttingen

    Göttingen,
    Germany

    Site Not Available

  • Hamburg, 20246
    Germany

    Site Not Available

  • Chai Wan,
    Hong Kong

    Site Not Available

  • Hong Kong,
    Hong Kong

    Site Not Available

  • Hongkong,
    Hong Kong

    Site Not Available

  • Kowloon,
    Hong Kong

    Site Not Available

  • Beer Sheva, 8410101
    Israel

    Site Not Available

  • Soroka University Medical Centre

    Beersheva,
    Israel

    Site Not Available

  • Kfar Saba, 4428164
    Israel

    Site Not Available

  • Tel Aviv, 6423906
    Israel

    Site Not Available

  • Zrifin, 6093000
    Israel

    Site Not Available

  • Meldola, Forlì 47014
    Italy

    Site Not Available

  • Candiolo, Torino 10060
    Italy

    Site Not Available

  • Bergamo, 24128
    Italy

    Site Not Available

  • Ospedale de Reggio

    Emilia,
    Italy

    Site Not Available

  • IRST di Meldola

    Forli,
    Italy

    Site Not Available

  • Milano, 20162
    Italy

    Site Not Available

  • Ospedale Silvestrini

    Perugia,
    Italy

    Site Not Available

  • Reggio Emilia, 42123
    Italy

    Site Not Available

  • IRCC-Candiolo

    Torino,
    Italy

    Site Not Available

  • Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • Bergen, 5021
    Norway

    Site Not Available

  • Nordlandssykehuset HF

    Bodo,
    Norway

    Site Not Available

  • Bodø, 8092
    Norway

    Site Not Available

  • Kristiansand, N-4604
    Norway

    Site Not Available

  • Oslo, N-0310
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Nord HF

    Tromso,
    Norway

    Site Not Available

  • Tromsø, 9038
    Norway

    Site Not Available

  • Trondheim, 7006
    Norway

    Site Not Available

  • Ã…lesund Hospital

    Ã…lesund,
    Norway

    Site Not Available

  • Ålesund, 6026
    Norway

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Klinika Urologii

    Bialystok,
    Poland

    Site Not Available

  • Bydgoszcz, 85-165
    Poland

    Site Not Available

  • Gliwice, 44-101
    Poland

    Site Not Available

  • Kielce, 25-734
    Poland

    Site Not Available

  • Krakow, 31-051
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie

    Kraków,
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie

    Kraków,
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 4w Lublinie

    Lublin,
    Poland

    Site Not Available

  • Luiblin, 20-954
    Poland

    Site Not Available

  • Warszawa, 02-781
    Poland

    Site Not Available

  • Wroclaw, 50-981
    Poland

    Site Not Available

  • Akademicki Szpital Kliniczny

    Wrocław,
    Poland

    Site Not Available

  • Akademicki Szpital Kliniczny

    Wrocław,
    Poland

    Site Not Available

  • Singapore, 258499
    Singapore

    Site Not Available

  • Faculty hospital F.D. Roosevelta

    Banska Bysterica,
    Slovakia

    Site Not Available

  • Banska Bystrica, 97517
    Slovakia

    Site Not Available

  • Bratislava, 83305
    Slovakia

    Site Not Available

  • Martin, 03659
    Slovakia

    Site Not Available

  • Presov, 08181
    Slovakia

    Site Not Available

  • Trnava, 917 01
    Slovakia

    Site Not Available

  • Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Alcorcón, Madrid 28922
    Spain

    Site Not Available

  • Barakaldo, Vizcaya 48903
    Spain

    Site Not Available

  • Barcelona, 08036
    Spain

    Site Not Available

  • H. Reina Sofía

    Córdoba,
    Spain

    Site Not Available

  • Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Alcorcon

    Madrid,
    Spain

    Site Not Available

  • Pamplona, 31008
    Spain

    Site Not Available

  • Valencia, 46026
    Spain

    Site Not Available

  • Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital in Gävle

    Gävle,
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Göteborg,
    Sweden

    Site Not Available

  • Hospital in Gävle

    Gävle,
    Sweden

    Site Not Available

  • Göteborg, 413 45
    Sweden

    Site Not Available

  • Länssjukhuset Ryhov

    Jönköping,
    Sweden

    Site Not Available

  • Jönköping, 551 85
    Sweden

    Site Not Available

  • Kalmar, 391 85
    Sweden

    Site Not Available

  • Malmö, 205 02
    Sweden

    Site Not Available

  • Sandviken, 80187
    Sweden

    Site Not Available

  • Stockholm, 171 76
    Sweden

    Site Not Available

  • Sundsvall, 851 86
    Sweden

    Site Not Available

  • Norrlands University Hospital

    Umeå,
    Sweden

    Site Not Available

  • Umeå, 901 85
    Sweden

    Site Not Available

  • Centrallasarettet Växjö

    Växjö,
    Sweden

    Site Not Available

  • Centrallasarettet Växjö

    Växjö,
    Sweden

    Site Not Available

  • Romford, Essex RM7 0AG
    United Kingdom

    Site Not Available

  • Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • Bebington, Merseyside CH63 4JY
    United Kingdom

    Site Not Available

  • Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Taunton, Somerset TA1 5DA
    United Kingdom

    Site Not Available

  • Ipswich, Suffolk IP4 5PD
    United Kingdom

    Site Not Available

  • Guildford, Surrey GU2 7XX
    United Kingdom

    Site Not Available

  • Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Coventry, Warwickshire CV2 2DX
    United Kingdom

    Site Not Available

  • Birmingham, West Midlands B15 2TH
    United Kingdom

    Site Not Available

  • Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Brighton, BN2 5BD
    United Kingdom

    Site Not Available

  • Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • Cardiff,
    United Kingdom

    Site Not Available

  • Castle Hill Hospital

    Cottingham,
    United Kingdom

    Site Not Available

  • Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Queen's Hospital

    Essex,
    United Kingdom

    Site Not Available

  • The Beatson Ventre

    Glasgow,
    United Kingdom

    Site Not Available

  • Hull, HU16 5JQ
    United Kingdom

    Site Not Available

  • Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Mount Vernon Hospital

    Middlesex,
    United Kingdom

    Site Not Available

  • Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Sheffield, S10 2SJ
    United Kingdom

    Site Not Available

  • Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southhampton General Hospital

    Southhampton,
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital

    Surrey,
    United Kingdom

    Site Not Available

  • University Hospital Warwick

    Warwick,
    United Kingdom

    Site Not Available

  • Clatterbridge Centre for Oncology

    Wirral,
    United Kingdom

    Site Not Available

  • Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • South Orange County Medical Research Center

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Los Angeles, California 90048-0750
    United States

    Site Not Available

  • Roseville, California 95661
    United States

    Site Not Available

  • Walter Reed Army Medical Center

    Washington, District of Columbia 20307
    United States

    Site Not Available

  • Tampa, Florida 33612
    United States

    Site Not Available

  • Advocate Lutheran General Center for Advanced Care

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Washington University School of medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis, Missouri 63110
    United States

    Site Not Available

  • Las Vegas, Nevada 89169
    United States

    Site Not Available

  • UNC Lineberger Comprehensive Cancer

    Chapel Hill, North Carolina 27599-7295
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19111-2497
    United States

    Site Not Available

  • DeBakey VA Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

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