check_circleStudy Completed

Prostatic Neoplasms

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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

Trial summary

Enrollment Goal
705
Trial Dates
July 2012 - February 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
PARIS CEDEX 15, 75908, France
Completed
Berlin, 12200, Germany
Completed
Dresden, 01307, Germany
Completed
Aachen, 52074, Germany
Withdrawn
Braunschweig, 38118, Germany
Withdrawn
Hannover, 30625, Germany
Completed
Frankfurt, 60590, Germany
Completed
München, 81377, Germany
Withdrawn
Göttingen, 37075, Germany
Withdrawn
Heidelberg, 69112, Germany
Completed
München, 81675, Germany
Completed
Mainz, 55131, Germany
Withdrawn
Hannover, 30559, Germany
Completed
Rostock, 18107, Germany
Completed
Berlin, 14197, Germany
Withdrawn
Berlin, 10967, Germany
Completed
Bremen, 28277, Germany
Completed
Erlangen, 91054, Germany
Completed
Magdeburg, 39120, Germany
Completed
Tübingen, 72076, Germany
Completed
Stockholm, 171 76, Sweden
Completed
Jena, 07740, Germany
Completed
Düsseldorf, 40225, Germany
Withdrawn
AMSTERDAM, 1081 HV, Netherlands
Withdrawn
ALKMAAR, 1815 JD, Netherlands
Completed
Lund, 221 85, Sweden
Completed
Uppsala, 751 85, Sweden
Completed
Linköping, 581 85, Sweden
Completed
Umeå, 901 85, Sweden
Completed
Kalmar, 391 85, Sweden
Completed
Sundsvall, 851 86, Sweden
Completed
Eskilstuna, 633 52, Sweden
Completed
Karlstad, 651 85, Sweden
Completed
Beer Sheva, 8410101, Israel
Completed
Kfar Saba, 4428164, Israel
Completed
Haifa, 3109601, Israel
Completed
Zerifin, 6093000, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Tel Aviv, 6423906, Israel
Completed
Galway, Ireland
Completed
Dublin 6, Ireland
Completed
Cork, Ireland
Completed
Meldola, 47014, Italy
Completed
Milano, 20133, Italy
Withdrawn
Bergamo, 24128, Italy
Withdrawn
Torino, 10060, Italy
Completed
Pisa, 56126, Italy
Withdrawn
Reggio Emilia, 42123, Italy
Completed
Lausanne, 1011, Switzerland
Completed
St. Gallen, 9007, Switzerland
Completed
Chur, 7000, Switzerland
Completed
Aarau, 5001, Switzerland
Completed
Basel, 4056, Switzerland
Withdrawn
Bellinzona, 6500, Switzerland
Completed
Bern, 3010, Switzerland
Completed
Zürich, 8091, Switzerland
Withdrawn
Rostock, 18057, Germany
Completed
Helsinki, 00180, Finland
Completed
Tampere, FIN-33520, Finland
Completed
HUS, 00029, Finland
Completed
Seinäjoki, 60220, Finland
Completed
Kuopio, 70210, Finland
Withdrawn
Sutton, SM2 5PT, United Kingdom
Withdrawn
MONTPELLIER CEDEX, 34298, France
Completed
Lørenskog, 1478, Norway
Completed
Bodø, 8092, Norway
Completed
Bergen, 5021, Norway
Completed
Oslo, 0424, Norway
Withdrawn
Oslo, Norway
Completed
Ålesund, 6026, Norway
Withdrawn
Sheffield, S10 2SJ, United Kingdom
Withdrawn
Cambridge, CB2 0QQ, United Kingdom
Withdrawn
Leeds, LS9 7TF, United Kingdom
Withdrawn
Derby, DE22 3NE, United Kingdom
Completed
Plymouth, PL6 8DH, United Kingdom
Withdrawn
Southampton, SO16 6YD, United Kingdom
Withdrawn
Taunton, TA1 5DA, United Kingdom
Withdrawn
Aberdeen, AB25 2ZN, United Kingdom
Withdrawn
Glasgow, G12 0YN, United Kingdom
Completed
Milano, 20089, Italy
Completed
Roma, 00161, Italy
Completed
Messina, 98125, Italy
Completed
Barcelona, 08035, Spain
Completed
Pamplona, 31008, Spain
Withdrawn
Valencia, 46014, Spain
Completed
Madrid, 28033, Spain
Completed
Santiago de Compostela, 15706, Spain
Completed
Malaga, 29010, Spain
Completed
Madrid, 28007, Spain
Completed
ZWOLLE, 8025 AB, Netherlands
Completed
NIJMEGEN, 6525 GA, Netherlands
Completed
Örebro, 715 92, Sweden
Completed
Bebington, CH63 4JY, United Kingdom
Withdrawn
Hull, HU16 5JQ, United Kingdom
Withdrawn
Cardiff, CF14 2TL, United Kingdom
Withdrawn
Romford, RM7 0AG, United Kingdom
Withdrawn
Recklinghausen, 45657, Germany
Withdrawn
Homburg, 66421, Germany
Completed
Berlin, 10719, Germany
Completed
Marburg, 35043, Germany
Completed
Freiburg im Breisgau, 79106, Germany
Withdrawn
Bonn, 53105, Germany
Withdrawn
LILLE CEDEX, 59020, France
Withdrawn
CAEN CEDEX 5, 14076, France
Withdrawn
SAINT HERBLAIN, 44805, France
Withdrawn
CLERMONT FERRAND CEDEX 1, 63011, France
Completed
Nottingham, NG5 1PB, United Kingdom
Withdrawn
PARIS, 75010, France
Withdrawn
VILLEJUIF CEDEX, 94805, France
Withdrawn
PARIS, 75674, France
Withdrawn
POITIERS cedex, 86021, France
Withdrawn
Grenoble, 38043, France
Withdrawn
MONTPELLIER, 34070, France
Completed
Torino, 10043, Italy
Withdrawn
Brescia, 25123, Italy
Completed
Genova, 16128, Italy
Withdrawn
Pordenone, 33081, Italy
Withdrawn
Bari, 70124, Italy
Withdrawn
Milano, 20162, Italy
Withdrawn
Herlev, 2730, Denmark
Withdrawn
København, 2100, Denmark
Withdrawn
Odense, 5000, Denmark
Completed
Ulm, 89075, Germany
Completed
Hamburg, 20246, Germany
Withdrawn
Bristol, BS2 8ED, United Kingdom
Completed
Barcelona, 08025, Spain
Completed
Barcelona, 08036, Spain
Completed
Palma de Mallorca, 07120, Spain
Completed
Madrid, 28046, Spain
Completed
Córdoba, 14004, Spain
Completed
Pamplona, 31008, Spain
Completed
Hospitalet de Llobregat, 08907, Spain
Withdrawn
Lugo, 27004, Spain
Withdrawn
León, 24008, Spain
Withdrawn
A Coruña, 15006, Spain
Withdrawn
Münster, 48149, Germany
Withdrawn
Chemnitz, 09119, Germany
Withdrawn
Greifswald, 17475, Germany
Withdrawn
Greifswald, 17475, Germany
Withdrawn
Wolverhampton, WV10 0QP, United Kingdom
Completed
Manchester, M20 4BX, United Kingdom
Completed
Belfast, BT9 7AB, United Kingdom
Completed
Coventry, CV2 2DX, United Kingdom
Withdrawn
Newcastle Upon Tyne, NE7 7DN, United Kingdom
Withdrawn
Birmingham, B15 2TH, United Kingdom
Completed
London, SE1 9RT, United Kingdom
Withdrawn
Northwood, HA6 2VR, United Kingdom
Completed
Guildford, GU2 7XX, United Kingdom
Withdrawn
Edinburgh, EH4 2XU, United Kingdom
Withdrawn
Leicester, LE1 5WW, United Kingdom
Withdrawn
ANGERS, 49933, France
Withdrawn
Vandoeuvre les Nancy, 54500, France
Withdrawn
LILLE, 59037, France
Withdrawn
LA ROCHE SUR YON cedex, 85925, France
Withdrawn
AVIGNON, 84000, France
Completed
Warszawa, 02-781, Poland
Withdrawn
Modena, 41124, Italy
Completed
Treviso, 31100, Italy
Completed
Arezzo, 52100, Italy
Withdrawn
Napoli, 80131, Italy
Withdrawn
Napoli, 80131, Italy
Completed
Trento, 38122, Italy
Withdrawn
Genova, 16132, Italy
Withdrawn
Brindisi, 72100, Italy
Withdrawn
Roma, 00144, Italy
Withdrawn
Milano, 20132, Italy
Withdrawn
Padova, 35128, Italy
Withdrawn
Cagliari, 09125, Italy
Completed
Roma, 00189, Italy
Completed
Roma, 00149, Italy
Withdrawn
Foggia, 71013, Italy
Withdrawn
Roma, 00168, Italy
Withdrawn
Edmonton, T6G 1Z2, Canada
Completed
Toronto, M5G 2M9, Canada
Completed
Vancouver, V5Z 4E6, Canada
Completed
Toronto, M4N 3M5, Canada
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
GENT, 9000, Belgium
Withdrawn
OTTIGNIES, 1340, Belgium
Withdrawn
BRUGGE, 8000, Belgium
Withdrawn
KORTRIJK, 8500, Belgium
Completed
LEUVEN, 3000, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Completed
BRUXELLES - BRUSSEL, 1090, Belgium
Withdrawn
LEIDEN, 2333 ZA, Netherlands
Withdrawn
Praha 4, 140 59, Czech Republic
Withdrawn
Ostrava, 708 52, Czech Republic
Withdrawn
Rehovot, 7610001, Israel
Completed
Ramat Gan, 5262000, Israel
Completed
Bialystok, 15-027, Poland
Withdrawn
TOULOUSE cedex, 31059, France
Withdrawn
Praha 5, 150 06, Czech Republic
Withdrawn
Plzen - Bory, 305 99, Czech Republic
Withdrawn
Brno, 656 91, Czech Republic
Withdrawn
Valencia, 46009, Spain
Withdrawn
Zaragoza, 50009, Spain
Completed
Santander, 39008, Spain
Completed
Madrid, 28041, Spain
Withdrawn
Las Palmas de Gran Canaria, 35020, Spain
Withdrawn
Salamanca, 37007, Spain
Withdrawn
Málaga, 29010, Spain
Completed
Sevilla, 41013, Spain
Withdrawn
Santa Cruz de Tenerife, 38009, Spain
Withdrawn
Sevilla, 41071, Spain
Withdrawn
Cruces/Barakaldo, 48903, Spain
Completed
Oviedo, 33006, Spain
Completed
Valencia, 46026, Spain
Completed
Ottawa, K1H 8L6, Canada
Completed
Montreal, H2L 4M1, Canada
Withdrawn
México, 14080, Mexico
Withdrawn
Mexico, D.F., 01120, Mexico
Completed
Obninsk, 249036, Russia
Completed
Moscow, 115478, Russia
Withdrawn
Obninsk, 249036, Russia
Withdrawn
Obninsk, 249036, Russia

Primary Outcome

  • 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
    date_rangeTime Frame:
    From baseline to 30 days post-treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    From 30 days post-treatment up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)
    date_rangeTime Frame:
    From baseline up to 1 year
    enhanced_encryption
    Safety Issue:
    No

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