Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
2 other identifiers
interventional
705
19 countries
215
Brief Summary
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Typical duration for phase_3
215 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2012
CompletedFirst Posted
Study publicly available on registry
June 13, 2012
CompletedStudy Start
First participant enrolled
July 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2016
CompletedMarch 31, 2017
March 1, 2017
2.1 years
June 11, 2012
March 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acute safety, variables will be summarized using descriptive statistics based on adverse events collection
Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry
From baseline to 30 days post-treatment
Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection
Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies
From 30 days post-treatment up to 3 years
Secondary Outcomes (1)
Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)
From baseline up to 1 year
Study Arms (1)
Radium-223 dichloride
EXPERIMENTALInterventions
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
Eligibility Criteria
You may qualify if:
- Age ≥18 years of age
- 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
- +1 more criteria
You may not qualify if:
- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (215)
Unknown Facility
Bruges, 8000, Belgium
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Bruxelles - Brussel, 1000, Belgium
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Bruxelles - Brussel, 1090, Belgium
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Bruxelles - Brussel, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Ottignies, 1340, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Brno, 656 91, 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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Prague, 150 06, Czechia
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Copenhagen, 2100, Denmark
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Herlev, 2730, Denmark
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Odense, 5000, Denmark
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Helsinki, 00180, Finland
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HUS, 00029, Finland
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Kuopio, 70211, Finland
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Seinäjoki, 60220, Finland
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Tampere, FIN-33520, Finland
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Angers, 49033, France
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Avignon, 84000, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Grenoble, 38043, France
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La Roche-sur-Yon, 85025, France
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Lille, 59020, France
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Lille, 59037, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Paris, 75010, France
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Paris, 75674, France
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Paris, 75908, France
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Poitiers, 86021, France
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Saint-Herblain, 44805, France
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Suresnes, 92151, France
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Toulouse, 31059, France
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VandÅ“uvre-lès-Nancy, 54500, France
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Villejuif, 94805, France
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Freiburg Im Breisgrau, Baden-Wurttemberg, 79106, Germany
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Heidelberg, Baden-Wurttemberg, 69112, Germany
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TĂ¼bingen, Baden-Wurttemberg, 72076, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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Erlangen, Bavaria, 91054, Germany
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MĂ¼nchen, Bavaria, 81377, Germany
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MĂ¼nchen, Bavaria, 81675, Germany
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Bremen, City state Bremen, 28277, 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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Braunschweig, Lower Saxony, 38118, Germany
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Göttingen, Lower Saxony, 37075, Germany
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Hanover, Lower Saxony, 30559, Germany
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Hanover, Lower Saxony, 30625, Germany
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Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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Rostock, Mecklenburg-Vorpommern, 18057, Germany
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Rostock, Mecklenburg-Vorpommern, 18107, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Bonn, North Rhine-Westphalia, 53105, Germany
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DĂ¼sseldorf, North Rhine-Westphalia, 40225, Germany
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MĂ¼nster, North Rhine-Westphalia, 48149, Germany
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Recklinghausen, North Rhine-Westphalia, 45657, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Chemnitz, Saxony, 09119, Germany
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Dresden, Saxony, 01307, Germany
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Berlin, State of Berlin, 10719, Germany
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Berlin, State of Berlin, 10967, Germany
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Berlin, State of Berlin, 12200, Germany
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Berlin, State of Berlin, 14197, Germany
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Jena, Thuringia, 07740, Germany
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Magdeburg, 39120, Germany
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Galway, Galway, Ireland
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Cork, Ireland
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Dublin, Ireland
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Beersheba, 8410101, Israel
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Haifa, 3109601, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 5262000, Israel
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Rehovot, 7610001, Israel
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Tel Aviv, 6423906, Israel
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Ẕerifin, 6093000, Israel
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Bari, Apulia, 70124, Italy
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Brindisi, Apulia, 72100, Italy
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Foggia, Apulia, 71013, Italy
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Napoli, Campania, 80131, Italy
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Forlì, Emilia-Romagna, 47014, Italy
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Modena, Emilia-Romagna, 41124, Italy
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Reggio Emilia, Emilia-Romagna, 42123, Italy
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Pordenone, Friuli Venezia Giulia, 33081, Italy
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Rome, Lazio, 00144, Italy
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Rome, Lazio, 00149, Italy
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Rome, Lazio, 00161, Italy
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Rome, Lazio, 00168, Italy
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Rome, Lazio, 00189, Italy
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Genoa, Liguria, 16128, Italy
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Genoa, Liguria, 16132, Italy
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Bergamo, Lombardy, 24128, Italy
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Brescia, Lombardy, 25123, Italy
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Milan, Lombardy, 20089, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20133, Italy
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Milan, Lombardy, 20162, Italy
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Turin, Piedmont, 10043, Italy
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Turin, Piedmont, 10060, Italy
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Cagliari, Sardinia, 09125, Italy
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Messina, Sicily, 98125, Italy
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Trento, Trentino-Alto Adige, 38122, Italy
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Arezzo, Tuscany, 52100, Italy
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Florence, Tuscany, 50134, Italy
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Pisa, Tuscany, 56126, Italy
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Padua, Veneto, 35128, Italy
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Treviso, Veneto, 31100, Italy
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Verona, Veneto, 37126, Italy
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Mexico City, Mexico City, 01120, Mexico
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Mexico City, Mexico City, 14080, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Zwolle, 8025 AB, Netherlands
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Ă…lesund, 6026, Norway
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Bergen, 5021, Norway
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Bodø, 8092, Norway
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Lørenskog, 1478, Norway
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Oslo, 0424, Norway
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Oslo, Norway
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Bialystok, 15-027, Poland
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Warsaw, 02-781, Poland
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Moscow, 115478, Russia
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Obninsk, 249036, Russia
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A Coruña, A Coruña, 15006, Spain
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Santiago de Compostela, A Coruña, 15706, Spain
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CĂ³rdoba, Andalusia, 14004, Spain
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Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Cruces/Barakaldo, Bilbao, 48903, Spain
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Santa Cruz de Tenerife, Canary Islands, 38009, Spain
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Santander, Cantabria, 39008, Spain
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Palma de Mallorca, Illes Baleares, Spain
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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain
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LeĂ³n, LeĂ³n, 24008, Spain
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Lugo, Lugo, 27004, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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MĂ¡laga, MĂ¡laga, 29010, Spain
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Oviedo, Oviedo, 33006, Spain
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Pamplona, Pamplona, 31008, Spain
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Salamanca, Salamanca, 37007, Spain
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Seville, Sevilla, 41013, Spain
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Seville, Sevilla, 41071, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46014, Spain
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Valencia, Valencia, 46026, Spain
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Madrid, 28007, Spain
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Madrid, 28033, Spain
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MĂ¡laga, 29010, Spain
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Zaragoza, 50009, Spain
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Eskilstuna, 633 52, Sweden
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Kalmar, 391 85, Sweden
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Karlstad, 651 85, Sweden
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Linköping, 581 85, Sweden
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Lund, 221 85, Sweden
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Ă–rebro, 715 92, Sweden
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Stockholm, 171 76, Sweden
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Sundsvall, 851 86, Sweden
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UmeĂ¥, 901 85, Sweden
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Uppsala, 751 85, Sweden
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Aarau, Canton of Aargau, 5001, Switzerland
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Basel, Canton of Basel-City, 4056, Switzerland
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Bern, Canton of Bern, 3010, Switzerland
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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
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Lausanne, Canton of Vaud, 1011, Switzerland
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Zurich, Canton of Zurich, 8091, Switzerland
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Bellinzona, Canton Ticino, 6500, Switzerland
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Chur, Kanton GraubĂ¼nden, 7000, Switzerland
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Bristol, Bristol, BS2 8ED, United Kingdom
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Cambridge, Cambridgeshire, CB2 0QQ, 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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Edinburgh, Lothian, EH4 2XU, 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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Northwood, Middlesex, HA6 2VR, 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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Sheffield, South Yorkshire, S10 2SJ, 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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Wolverhampton, West Midlands, WV10 0QP, United Kingdom
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Aberdeen, AB25 2ZN, United Kingdom
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Belfast, BT9 7AB, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Derby, DE22 3NE, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE1 9RT, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Southampton, SO16 6YD, United Kingdom
Related Publications (3)
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.
PMID: 31311763DERIVEDHeidenreich 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.
PMID: 30612558DERIVEDSaad 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.
PMID: 27473888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2012
First Posted
June 13, 2012
Study Start
July 22, 2012
Primary Completion
August 13, 2014
Study Completion
February 28, 2016
Last Updated
March 31, 2017
Record last verified: 2017-03