check_circleStudy Completed
Prostatic Neoplasms
Bayer Identifier:
16216
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
705Trial Dates
July 2012 - February 2016Phase
Phase 3Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | PARIS CEDEX 15, 75908, France | |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Withdrawn | Braunschweig, 38118, Germany | |
Withdrawn | Hannover, 30625, Germany | |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Withdrawn | Göttingen, 37075, Germany | |
Withdrawn | Heidelberg, 69112, Germany | |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Withdrawn | Hannover, 30559, Germany | |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Withdrawn | Berlin, 10967, Germany | |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Withdrawn | AMSTERDAM, 1081 HV, Netherlands | |
Withdrawn | ALKMAAR, 1815 JD, Netherlands | |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 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 chemistrydate_rangeTime Frame:From baseline to 30 days post-treatmentenhanced_encryptionYesSafety Issue:
- 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 malignanciesdate_rangeTime Frame:From 30 days post-treatment up to 3 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)date_rangeTime Frame:From baseline up to 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1