Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
NCT ID: NCT01618370
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
705 participants
INTERVENTIONAL
2012-07-22
2016-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radium-223 dichloride
Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
Interventions
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Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed prostate cancer
* Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
* Progressive disease is defined either by:
* The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
* In the absence of new bone lesions by 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met)
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2
* Adequate hematological, liver, and renal function
* Absolute neutrophil count (ANC) ≥ 1.5 x10\^9/L
* Platelet count ≥ 100 x10\^9/L
* Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Creatinine ≤ 1.5 x ULN
* Albumin \> 25 g/L
Exclusion Criteria
* Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
* Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
* Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
* Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
* Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
* Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
* Presence of brain metastases
* Lymphadenopathy exceeding 6 cm in short-axis diameter
* Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
* Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
* Any other serious illness or medical condition, such as but not limited to:
* Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
* Cardiac failure New York Heart Association (NYHA) III or IV
* Crohn's disease or ulcerative colitis
* Bone marrow dysplasia
* Fecal incontinence
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bruges, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Ottignies, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Brno, , Czechia
Ostrava, , Czechia
Plzen - Bory, , Czechia
Prague, , Czechia
Prague, , Czechia
Copenhagen, , Denmark
Herlev, , Denmark
Odense, , Denmark
Helsinki, , Finland
HUS, , Finland
Kuopio, , Finland
Seinäjoki, , Finland
Tampere, , Finland
Angers, , France
Avignon, , France
Caen, , France
Clermont-Ferrand, , France
Grenoble, , France
La Roche-sur-Yon, , France
Lille, , France
Lille, , France
Montpellier, , France
Montpellier, , France
Paris, , France
Paris, , France
Paris, , France
Poitiers, , France
Saint-Herblain, , France
Suresnes, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Freiburg Im Breisgrau, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Bremen, City state Bremen, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Braunschweig, Lower Saxony, Germany
Göttingen, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Rostock, Mecklenburg-Vorpommern, Germany
Rostock, Mecklenburg-Vorpommern, Germany
Aachen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Recklinghausen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Chemnitz, Saxony, Germany
Dresden, Saxony, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Jena, Thuringia, Germany
Magdeburg, , Germany
Galway, Galway, Ireland
Cork, , Ireland
Dublin, , Ireland
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Bari, Apulia, Italy
Brindisi, Apulia, Italy
Foggia, Apulia, Italy
Napoli, Campania, Italy
Forlì, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Pordenone, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Genoa, Liguria, Italy
Bergamo, Lombardy, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Turin, Piedmont, Italy
Cagliari, Sardinia, Italy
Messina, Sicily, Italy
Trento, Trentino-Alto Adige, Italy
Arezzo, Tuscany, Italy
Florence, Tuscany, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Treviso, Veneto, Italy
Verona, Veneto, Italy
Mexico City, Mexico City, Mexico
Mexico City, Mexico City, Mexico
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Leiden, , Netherlands
Nijmegen, , Netherlands
Zwolle, , Netherlands
Ålesund, , Norway
Bergen, , Norway
Bodø, , Norway
Lørenskog, , Norway
Oslo, , Norway
Oslo, , Norway
Bialystok, , Poland
Warsaw, , Poland
Moscow, , Russia
Obninsk, , Russia
A Coruña, A Coruña, Spain
Santiago de Compostela, A Coruña, Spain
Córdoba, Andalusia, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Cruces/Barakaldo, Bilbao, Spain
Santa Cruz de Tenerife, Canary Islands, Spain
Santander, Cantabria, Spain
Palma de Mallorca, Illes Baleares, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
León, León, Spain
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Málaga, Spain
Oviedo, Oviedo, Spain
Pamplona, Pamplona, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Zaragoza, , Spain
Eskilstuna, , Sweden
Kalmar, , Sweden
Karlstad, , Sweden
Linköping, , Sweden
Lund, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Aarau, Canton of Aargau, Switzerland
Basel, Canton of Basel-City, Switzerland
Bern, Canton of Bern, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Lausanne, Canton of Vaud, Switzerland
Zurich, Canton of Zurich, Switzerland
Bellinzona, Canton Ticino, Switzerland
Chur, Kanton Graubünden, Switzerland
Bristol, Bristol, United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Romford, Essex, United Kingdom
Leicester, Leicestershire, United Kingdom
Edinburgh, Lothian, United Kingdom
Manchester, Manchester, United Kingdom
Bebington, Merseyside, United Kingdom
Northwood, Middlesex, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Taunton, Somerset, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Guildford, Surrey, United Kingdom
Sutton, Surrey, United Kingdom
Coventry, Warwickshire, United Kingdom
Birmingham, West Midlands, United Kingdom
Wolverhampton, West Midlands, United Kingdom
Aberdeen, , United Kingdom
Belfast, , United Kingdom
Cardiff, , United Kingdom
Derby, , United Kingdom
Glasgow, , United Kingdom
Hull, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Saad F, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Nilsson S, Miller K, Wirth M, Reeves J, Seger M, Carles J, Heidenreich A. Disease Characteristics and Completion of Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Radium-223 in an International Early Access Program. Clin Genitourin Cancer. 2019 Oct;17(5):348-355.e5. doi: 10.1016/j.clgc.2019.05.012. Epub 2019 May 31.
Heidenreich A, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Carles J, Wirth M, Miller K, Reeves J, Seger M, Nilsson S, Saad F. Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program. BMC Cancer. 2019 Jan 7;19(1):12. doi: 10.1186/s12885-018-5203-y.
Saad F, Carles J, Gillessen S, Heidenreich A, Heinrich D, Gratt J, Levy J, Miller K, Nilsson S, Petrenciuc O, Tucci M, Wirth M, Federhofer J, O'Sullivan JM; Radium-223 International Early Access Program Investigators. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Sep;17(9):1306-16. doi: 10.1016/S1470-2045(16)30173-5. Epub 2016 Jul 26.
Other Identifiers
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2012-000075-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16216
Identifier Type: -
Identifier Source: org_study_id
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