Trial Condition(s):
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases
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.
- 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 -- Albumin > 25 g/L
- 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 -- Bone marrow dysplasia - Fecal incontinence
Locations | Status | ||
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Locations Investigative Site Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Aachen, Germany, 52074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rostock, Germany, 18107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Berlin, Germany, 14197 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bremen, Germany, 28277 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Erlangen, Germany, 91054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Jena, Germany, 07740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Uppsala, Sweden, 751 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Linköping, Sweden, 581 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kalmar, Sweden, 391 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sundsvall, Sweden, 851 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Eskilstuna, Sweden, 633 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Karlstad, Sweden, 651 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zerifin, Israel, 6093000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Galway, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dublin 6, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cork, Ireland | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Meldola, Italy, 47014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lausanne, Switzerland, 1011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Gallen, Switzerland, 9007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chur, Switzerland, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Aarau, Switzerland, 5001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Basel, Switzerland, 4056 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zürich, Switzerland, 8091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Helsinki, Finland, 00180 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Tampere, Finland, FIN-33520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site HUS, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seinäjoki, Finland, 60220 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kuopio, Finland, 70210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lørenskog, Norway, 1478 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bodø, Norway, 8092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bergen, Norway, 5021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oslo, Norway, 0424 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ålesund, Norway, 6026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Plymouth, United Kingdom, PL6 8DH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roma, Italy, 00161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Messina, Italy, 98125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pamplona, Spain, 31008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Malaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Örebro, Sweden, 715 92 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bebington, United Kingdom, CH63 4JY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Berlin, Germany, 10719 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Marburg, Germany, 35043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Freiburg im Breisgau, Germany, 79106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Torino, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Genova, Italy, 16128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ulm, Germany, 89075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Palma de Mallorca, Spain, 07120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Belfast, United Kingdom, BT9 7AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Coventry, United Kingdom, CV2 2DX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, United Kingdom, SE1 9RT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Treviso, Italy, 31100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Arezzo, Italy, 52100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Trento, Italy, 38122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roma, Italy, 00189 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roma, Italy, 00149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Vancouver, Canada, V5Z 4E6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bialystok, Poland, 15-027 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santander, Spain, 39008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oviedo, Spain, 33006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Montreal, Canada, H2L 4M1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Obninsk, Russia, 249036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 115478 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1