Trial Condition(s):
Prostatic Neoplasms
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases
Bayer Identifier:
16216
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rostock, Germany, 18107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 14197 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bremen, Germany, 28277 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kalmar, Sweden, 391 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sundsvall, Sweden, 851 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eskilstuna, Sweden, 633 52 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlstad, Sweden, 651 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 6093000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Galway, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin 6, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cork, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meldola, Italy, 47014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chur, Switzerland, 7000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, FIN-33520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HUS, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seinäjoki, Finland, 60220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuopio, Finland, 70210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lørenskog, Norway, 1478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bodø, Norway, 8092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergen, Norway, 5021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ålesund, Norway, 6026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plymouth, United Kingdom, PL6 8DH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Messina, Italy, 98125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 715 92 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bebington, United Kingdom, CH63 4JY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10719 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Freiburg im Breisgau, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ulm, Germany, 89075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belfast, United Kingdom, BT9 7AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coventry, United Kingdom, CV2 2DX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE1 9RT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Treviso, Italy, 31100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Arezzo, Italy, 52100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trento, Italy, 38122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 4E6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santander, Spain, 39008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H2L 4M1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Obninsk, Russia, 249036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115478 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Primary Outcome
- Acute safety, variables will be summarized using descriptive statistics based on adverse events collectionSafety 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 chemistryTimeframe: From baseline to 30 days post-treatment
- Long-term safety, variables will be summarized using descriptive statistics based on adverse events collectionSafety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignanciesTimeframe: From 30 days post-treatment up to 3 years
Secondary Outcome
- Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)Timeframe: From baseline up to 1 year
Additional Information
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