A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases (ALSYMPCA)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Collaborator:
Algeta ASA
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00699751
First received: June 17, 2008
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
Alsympca 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hormone Refractory Prostate Cancer Bone Metastases |
Drug: Radium-223 dichloride (BAY88-8223) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Overall survival [ Time Frame: Time from date of randomisation to the date of event ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to occurrence of specific disease events [ Time Frame: Time to first on-study specific disease events ] [ Designated as safety issue: Yes ]
- Changes and time to progression in PSA [ Time Frame: Study duration ] [ Designated as safety issue: No ]
- Changes and time to progression in total-ALP [ Time Frame: Study duration ] [ Designated as safety issue: No ]
- Safety endpoints; Adverse events, laboratory values, potential manifestations of late toxicity [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Clinical benefit endpoints: Performance status, Health related Quality of Life [ Time Frame: Study duration ] [ Designated as safety issue: No ]
| Enrollment: | 921 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radium-223 dichloride
Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals
|
Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals
Other Name: Alpharadin
|
|
Placebo Comparator: Placebo
Isotonic saline for 6 IV administrations separated by 4 weeks intervals
|
Drug: Placebo
Isotonic saline 6 IV administrations separated by 4 weeks intervals
|
Detailed Description:
The aim of the study is to compare, in patients with symptomatic 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 will be randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consists of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration.
Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals.
All patients received BSoC (Best Standard of Care).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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 pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699751
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Los Angeles, California, United States, 90048-0750 | |
| Roseville, California, United States, 95661 | |
| United States, Florida | |
| Tampa, Florida, United States, 33612 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Australia, New South Wales | |
| Liverpool, New South Wales, Australia, 2170 | |
| Randwick, New South Wales, Australia, 2031 | |
| St Leonards, New South Wales, Australia, 2065 | |
| Sydney, New South Wales, Australia, 2010 | |
| Wahroonga, New South Wales, Australia, 2076 | |
| Wollongong, New South Wales, Australia, 2521 | |
| Australia, Queensland | |
| Brisbane, Queensland, Australia, 4029 | |
| Toowoomba, Queensland, Australia, 4350 | |
| Australia, South Australia | |
| Adelaide, South Australia, Australia, 5000 | |
| Adelaide, South Australia, Australia, 5011 | |
| Australia, Tasmania | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Fitzroy, Victoria, Australia, 3065 | |
| Australia, Western Australia | |
| Nedlands, Western Australia, Australia, 6009 | |
| Belgium | |
| Kortrijk, Belgium, 8500 | |
| Ottignies, Belgium, 1340 | |
| Brazil | |
| Salvador, Bahia, Brazil, 41830-492 | |
| Belo Horizonte, Minas Gerais, Brazil, 30110-090 | |
| Porto Alegre, Rio Grande do Sul, Brazil | |
| Barretos, Sao Paulo, Brazil, 14784400 | |
| Piracicaba, Sao Paulo, Brazil | |
| Belo Horizonte, Brazil, 30380490 | |
| Rio de Janeiro, Brazil, 20551 030 | |
| Sao Paulo, Brazil, 05403-900 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| London, Ontario, Canada, N6A 4G5 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Czech Republic | |
| Brno, Czech Republic, 65653 | |
| Chomutov, Czech Republic, 430 12 | |
| Olomouc, Czech Republic, 775 20 | |
| Ostrava, Czech Republic, 708 52 | |
| Plzen - Bory, Czech Republic, 305 99 | |
| Praha 4, Czech Republic, 140 59 | |
| Usti nad Labem, Czech Republic, 401 13 | |
| France | |
| La Roche Sur Yon, France, 85925 | |
| Montbeliard, France, 25209 | |
| Saint Cloud, France, 92210 | |
| Germany | |
| Ulm, Baden-Württemberg, Germany, 89075 | |
| Frankfurt, Hessen, Germany, 60590 | |
| Marburg, Hessen, Germany, 35043 | |
| Göttingen, Niedersachsen, Germany, 37075 | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Dortmund, Nordrhein-Westfalen, Germany, 44137 | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Berlin, Germany, 10967 | |
| Berlin, Germany, 14197 | |
| Hamburg, Germany, 20246 | |
| Hong Kong | |
| Chai Wan, Hong Kong | |
| Hong Kong, Hong Kong | |
| Hongkong, Hong Kong | |
| Kowloon, Hong Kong | |
| Israel | |
| Beer Sheva, Israel, 84101 | |
| Kfar Saba, Israel, 44281 | |
| Tel Aviv, Israel, 64239 | |
| Zrifin, Israel, 70300 | |
| Italy | |
| Meldola, Forlì, Italy, 47014 | |
| Candiolo, Torino, Italy, 10060 | |
| Bergamo, Italy, 24128 | |
| Milano, Italy, 20162 | |
| Reggio Emilia, Italy, 42100 | |
| Netherlands | |
| Alkmaar, Netherlands, 1815 JD | |
| Nijmegen, Netherlands, 6532 SZ | |
| Rotterdam, Netherlands, 3015 CE | |
| Norway | |
| Bergen, Norway, 5021 | |
| Bodø, Norway, 8092 | |
| Kristiansand, Norway, N-4604 | |
| Oslo, Norway, 0450 | |
| Oslo, Norway, N-0310 | |
| Tromsø, Norway, 9038 | |
| Trondheim, Norway, 7006 | |
| Ålesund, Norway, 6026 | |
| Poland | |
| Bydgoszcz, Poland, 85-165 | |
| Gliwice, Poland, 44-101 | |
| Kielce, Poland, 25-734 | |
| Krakow, Poland, 31-051 | |
| Luiblin, Poland, 20-954 | |
| Warszawa, Poland, 02-781 | |
| Wroclaw, Poland, 50-981 | |
| Wroclaw, Poland, 50 - 556 | |
| Singapore | |
| Singapore, Singapore, 308433 | |
| Singapore, Singapore, 258499 | |
| Slovakia | |
| Banska Bystrica, Slovakia, 97517 | |
| Bratislava, Slovakia, 83305 | |
| Bratislava, Slovakia, 82606 | |
| Martin, Slovakia, 03659 | |
| Presov, Slovakia, 08181 | |
| Trnava, Slovakia, 917 01 | |
| Spain | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Alcorcón, Madrid, Spain, 28922 | |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08025 | |
| Barcelona, Spain, 08036 | |
| Córdoba, Spain, 14004 | |
| Pamplona, Spain, 31008 | |
| Valencia, Spain, 46026 | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Göteborg, Sweden, 413 45 | |
| Jönköping, Sweden, 551 85 | |
| Kalmar, Sweden, 391 85 | |
| Malmö, Sweden, 205 02 | |
| Sandviken, Sweden, 80187 | |
| Stockholm, Sweden, 171 76 | |
| Sundsvall, Sweden, 851 86 | |
| Umeå, Sweden, 901 85 | |
| United Kingdom | |
| Romford, Essex, United Kingdom, RM7 0AG | |
| Leicester, Leicestershire, United Kingdom, LE1 5WW | |
| Bebington, Merseyside, United Kingdom, CH63 4JY | |
| Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
| Taunton, Somerset, United Kingdom, TA1 5DA | |
| Ipswich, Suffolk, United Kingdom, IP4 5PD | |
| Guildford, Surrey, United Kingdom, GU2 7XX | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Coventry, Warwickshire, United Kingdom, CV2 2DX | |
| Birmingham, West Midlands, United Kingdom, B15 2TH | |
| Belfast, United Kingdom, BT9 7AB | |
| Brighton, United Kingdom, BN2 5BD | |
| Bristol, United Kingdom, BS2 8ED | |
| Cardiff, United Kingdom | |
| Derby, United Kingdom, DE22 3NE | |
| Hull, United Kingdom, HU16 5JQ | |
| Leeds, United Kingdom, LS9 7TF | |
| Manchester, United Kingdom, M20 4BX | |
| Northwood, United Kingdom, HA6 2RN | |
| Plymouth, United Kingdom, PL6 8DH | |
| Sheffield, United Kingdom, S10 2SJ | |
| Southampton, United Kingdom, SO16 6YD | |
| Wolverhampton, United Kingdom, WV10 0QP | |
Sponsors and Collaborators
Bayer
Algeta ASA
Investigators
| Study Chair: | Christopher Parker, M.D. | The Royal Marsden Hospital, UK |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00699751 History of Changes |
| Other Study ID Numbers: | 15245, BC1-06 |
| Study First Received: | June 17, 2008 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Ministry of Social Affairs, Public Health and the Environment Brazil: Ministry of Health Canada: Canadian Institutes of Health Research Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hong Kong: Department of Health Italy: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Singapore: Health Sciences Authority Spain: Spanish Agency of Medicines Slovakia: State Institute for Drug Control Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Israel: Israeli Health Ministry Pharmaceutical Administration United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Hormone Refractory Prostate Cancer Bone Metastases Radium-223 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
Bone Diseases Musculoskeletal Diseases Hematologic Diseases Succinylcholine Hormones Neuromuscular Depolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013