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

NCT00699751 | Completed Phase 3 Results DMC

• 3 other identifiers: 15245BC1-062007-006195-11
• Study Type: interventional
• Target: 921
• Locations: 19 countries
• Sites: 134

Brief 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.

Conditions

Bone Metastases; Hormone Refractory Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer; Bone Metastases; Radium-223

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from date of randomization to the date of death.

  From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)

Secondary Outcomes (23)

• Time to Total Alkaline Phosphatase (ALP) Progression

  From randomization to first ALP progression until approximately 3 years after start of enrollment

• Percentage of Participants With Total ALP Response at Week 12

  At Baseline and Week 12

• Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)

  At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)

• Percentage of Participants With Total ALP Normalization at Week 12

  At Baseline and Week 12

• Percentage Change From Baseline in Total ALP at Week 12

  At Baseline and Week 12

Other Outcomes (16)

• Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.

  Week 0

• Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.

  Week 8

• Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.

  Week 16

Study Arms (2)

Radium-223 dichloride (Xofigo, BAY88-8223)

EXPERIMENTAL

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).

Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Best standard of care (BSoC)

Placebo

PLACEBO COMPARATOR

Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).

Drug: Placebo; Drug: Best standard of care (BSoC)

Interventions

Best standard of care (BSoC) DRUG

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; Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

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

Also known as: Alpharadin

Radium-223 dichloride (Xofigo, BAY88-8223)

Placebo DRUG

Isotonic saline 6 IV administrations separated by 4 weeks intervals.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (134)

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Los Angeles, California, 90048-0750, United States

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Roseville, California, 95661, United States

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Tampa, Florida, 33612-9416, United States

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New Orleans, Louisiana, 70112, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89169, United States

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Philadelphia, Pennsylvania, 19111-2497, United States

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Liverpool, New South Wales, 2170, Australia

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Randwick, New South Wales, 2031, Australia

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St Leonards, New South Wales, 2065, Australia

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Sydney, New South Wales, 2010, Australia

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Wahroonga, New South Wales, 2076, Australia

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Wollongong, New South Wales, 2521, Australia

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Herston, Queensland, 4006, Australia

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Toowoomba, Queensland, 4350, Australia

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Adelaide, South Australia, 5000, Australia

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Woodville South, South Australia, 5011, Australia

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Hobart, Tasmania, 7000, Australia

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Fitzroy, Victoria, 3065, Australia

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Nedlands, Western Australia, 6009, Australia

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Kortrijk, 8500, Belgium

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Ottignies, 1340, Belgium

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Salvador, Estado de Bahia, 41950-640, Brazil

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Belo Horizonte, Minas Gerais, 30110-090, Brazil

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Rio de Janeiro, Rio de Janeiro, 20551 030, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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Piracicaba, São Paulo, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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Belo Horizonte, 30380490, Brazil

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Edmonton, Alberta, T6G 1Z2, Canada

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London, Ontario, N6A 4G5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Brno, 65653, Czechia

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Chomutov, 430 12, Czechia

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Olomouc, 77900, Czechia

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Ostrava, 708 52, Czechia

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Plzen - Bory, 305 99, Czechia

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Prague, 140 59, Czechia

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Usti n/Labem, 401 13, Czechia

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La Roche-sur-Yon, 85925, France

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Montbéliard, 25209, France

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Saint-Cloud, 92210, France

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Ulm, Baden-Wurttemberg, 89075, Germany

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Hamburg, Hamburg, 20246, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Marburg, Hesse, 35043, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30625, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Berlin, State of Berlin, 10967, Germany

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Berlin, State of Berlin, 14197, Germany

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Chai Wan, Hong Kong

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Beersheba, 8410101, Israel

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Kfar Saba, 4428164, Israel

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Tel Aviv, 6423906, Israel

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Zrifin, 7030000, Israel

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Forlì Cesena, Emilia-Romagna, 47014, Italy

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Reggio Emilia, Emilia-Romagna, 42123, Italy

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Bergamo, Lombardy, 24128, Italy

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Milan, Lombardy, 20162, Italy

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Turin, Piedmont, 10060, Italy

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Alkmaar, 1815 JD, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Ålesund, TBC, Norway

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Bergen, 5021, Norway

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Bodø, 8092, Norway

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Kristiansand, N-4604, Norway

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Oslo, 0379, Norway

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Oslo, 450, Norway

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Tromsø, 9038, Norway

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Trondheim, 7030, Norway

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Bydgoszcz, 85-165, Poland

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Gliwice, 44-101, Poland

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Kielce, 25-734, Poland

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Krakow, 31-051, Poland

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Luiblin, 20-954, Poland

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Warsaw, 02-781, Poland

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Wroclaw, 50 - 556, Poland

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Wroclaw, 50-981, Poland

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Singapore, 258499, Singapore

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Singapore, 308433, Singapore

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Banská Bystrica, 97517, Slovakia

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Bratislava, 82606, Slovakia

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Bratislava, 83305, Slovakia

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Martin, 03659, Slovakia

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Prešov, 08181, Slovakia

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Trnava, 917 01, Slovakia

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Santiago de Compostela, A Coruña, 15706, Spain

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Barcelona, Barcelona, 08023, Spain

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Barcelona, Barcelona, 8036, Spain

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Barcelona, Barcelona, 8041, Spain

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Córdoba, Córdoba, 14004, Spain

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Alcorcón, Madrid, 28922, Spain

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Pamplona, Pamplona, 31008, Spain

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Valencia, Valencia, 46026, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Gothenburg, 413 45, Sweden

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Jönköping, 551 85, Sweden

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Kalmar, 391 85, Sweden

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Malmo, 205 02, Sweden

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Sandviken, 80187, Sweden

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Stockholm, 171 76, Sweden

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Sundsvall, 851 86, Sweden

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Umeå, 901 85, Sweden

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Bristol, Bristol, BS2 8ED, United Kingdom

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Romford, Essex, RM7 0AG, United Kingdom

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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Manchester, Manchester, M20 4BX, United Kingdom

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Bebington, Merseyside, CH63 4JY, United Kingdom

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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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Taunton, Somerset, TA1 5DA, United Kingdom

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Ipswich, Suffolk, IP4 5PD, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Coventry, Warwickshire, CV2 2DX, United Kingdom

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Birmingham, West Midlands, B15 2TH, United Kingdom

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Belfast, BT9 7AB, United Kingdom

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Brighton, BN2 5BD, United Kingdom

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Cardiff, United Kingdom

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Derby, DE22 3NE, United Kingdom

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Hull, HU16 5JQ, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (11)

• 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.

  PMID: 23863050 RESULT

• 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.

  PMID: 25439694 RESULT

• 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.

  PMID: 24836273 RESULT

• 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.

  PMID: 25840395 RESULT

• 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.

  PMID: 25832684 RESULT

• 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.

  PMID: 24857093 RESULT

• 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.

  PMID: 24775727 RESULT

• 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.

  PMID: 24610703 RESULT

• 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.

  PMID: 24052017 RESULT

• 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.

  PMID: 23977665 RESULT

• 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.

  PMID: 27930924 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
• Integrating radium-223 therapy into the management of metastatic prostate cancer care: a plain language summary

MeSH Terms

Interventions

radium Ra 223 dichloride

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Christopher Parker, MD

  The Royal Marsden Hospital, UK

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: June 12, 2008
• Primary Completion: July 15, 2011
• Study Completion: February 13, 2014
• Last Updated: February 23, 2026
• Results First Posted: May 7, 2014

Record last verified: 2026-02

Locations

CA (4); NL (3); AU (13); SE (8); NO (8); GB (23); FR (3); HK (3); CZ (7); BR (8); SL (6); SG (2); PL (8); IT (5); DE (10); US (7); IL (4); BE (2); ES (10)