A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
NCT ID: NCT00699751
Last Updated: 2016-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
921 participants
INTERVENTIONAL
2008-06-30
2014-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Radium-223 dichloride (Xofigo, BAY88-8223)
Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
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.
Placebo
Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Placebo
Isotonic saline 6 IV administrations separated by 4 weeks intervals.
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.
Interventions
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Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
Placebo
Isotonic saline 6 IV administrations separated by 4 weeks intervals.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria
* Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
* Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
* Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
* Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
* History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Parker, MD
Role: STUDY_CHAIR
The Royal Marsden Hospital, UK
Locations
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Los Angeles, California, United States
Roseville, California, United States
Tampa, Florida, United States
New Orleans, Louisiana, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Philadelphia, Pennsylvania, United States
Liverpool, New South Wales, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Sydney, New South Wales, Australia
Wahroonga, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Toowoomba, Queensland, Australia
Adelaide, South Australia, Australia
Adelaide, South Australia, Australia
Hobart, Tasmania, Australia
Fitzroy, Victoria, Australia
Nedlands, Western Australia, Australia
Kortrijk, , Belgium
Ottignies, , Belgium
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Barretos, São Paulo, Brazil
Piracicaba, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Belo Horizonte, , Brazil
Edmonton, Alberta, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Brno, , Czechia
Chomutov, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Plzen - Bory, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
La Roche-sur-Yon, , France
Montbéliard, , France
Saint-Cloud, , France
Ulm, Baden-Wurttemberg, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Göttingen, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Dortmund, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Chai Wan, , Hong Kong
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Zrifin, Israel, Israel
Beersheba, , Israel
Kfar Saba, , Israel
Tel Aviv, , Israel
Meldola, Forlì, Italy
Candiolo, Torino, Italy
Bergamo, , Italy
Milan, , Italy
Reggio Emilia, , Italy
Alkmaar, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Ålesund, , Norway
Bergen, , Norway
Bodø, , Norway
Kristiansand, , Norway
Oslo, , Norway
Oslo, , Norway
Tromsø, , Norway
Trondheim, , Norway
Bydgoszcz, , Poland
Gliwice, , Poland
Kielce, , Poland
Krakow, , Poland
Luiblin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Martin, , Slovakia
Prešov, , Slovakia
Trnava, , Slovakia
Santiago de Compostela, A Coruña, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Córdoba, Córdoba, Spain
Alcorcón, Madrid, Spain
Pamplona, Pamplona, Spain
Valencia, Valencia, Spain
Barakaldo, Vizcaya, Spain
Zaragoza, Zaragoza, Spain
Gothenburg, , Sweden
Jönköping, , Sweden
Kalmar, , Sweden
Malmo, , Sweden
Sandviken, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Umeå, , Sweden
Bristol, Bristol, United Kingdom
Romford, Essex, United Kingdom
Leicester, Leicestershire, United Kingdom
Manchester, Manchester, United Kingdom
Bebington, Merseyside, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Taunton, Somerset, United Kingdom
Ipswich, Suffolk, United Kingdom
Guildford, Surrey, United Kingdom
Sutton, Surrey, United Kingdom
Coventry, Warwickshire, United Kingdom
Birmingham, West Midlands, United Kingdom
Belfast, , United Kingdom
Brighton, , United Kingdom
Cardiff, , United Kingdom
Derby, , United Kingdom
Hull, , United Kingdom
Leeds, , United Kingdom
Northwood, , United Kingdom
Plymouth, , United Kingdom
Sheffield, , United Kingdom
Southampton, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.
Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.
Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland OS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.
Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.
Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061.
Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132.
Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6.
Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4.
Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19.
Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.
Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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BC1-06
Identifier Type: OTHER
Identifier Source: secondary_id
2007-006195-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15245
Identifier Type: -
Identifier Source: org_study_id
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