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Sponsored by: |
Algeta ASA |
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Information provided by: | Algeta ASA |
ClinicalTrials.gov Identifier: | NCT00337155 |
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer Neoplasm Metastasis |
Drug: Radium-223 (Alpharadin ) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Randomised, Dose Finding, Repeat Dose, Phase II, Multicentre Study of AlpharadinTM for the Treatment of Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases. |
Estimated Enrollment: | 117 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 |
Drug: Radium-223 (Alpharadin )
3 doses of Alpharadin (radium-223) at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hormone refractory with evidence of rising PSA:
Patients who have received prior hormonal drug therapy:
Elevated and rising PSA:
Laboratory requirements:
Exclusion Criteria:
Any other serious illness or medical condition, for example:
United Kingdom, Surrey | |
The Royal Marsden Hospital | |
Sutton, Surrey, United Kingdom, SM2 5RT |
Principal Investigator: | Chrisopher Parker, MD | The Royal Marsden Hospital, Sutton, UK |
Principal Investigator: | O'Sullivan Joe, MD | Belfast City Hospital, Lisburn Road, Belfast BT9 7AB, UK |
Principal Investigator: | Hoskin Peter, MD | Mount Vernon Hospital, Cancer Centre, Northwood, Midddelsex, HA6 2RN, UK |
Principal Investigator: | Tyrrell Christopher, MD | Plymouth Oncology Centre, Derriford Hospital, Plymouth, PL6 8DH, UK |
Principal Investigator: | Bottomly David, MD | Cookridge Hospital, Hospital Lane, leeds LS16 6QB, UK |
Principal Investigator: | Mellado Begona, MD | Hospital Clinic, c/Villarroel, 170, Barcelona, Spain |
Principal Investigator: | Maroto Pablo, MD | Hospital St Pau, Medical Oncology, Av. Sant Antoni M. Claret, 167, Barcelona, Spain |
Principal Investigator: | Andres Redondo, MD | Hospital La Paz, Paseo de la Castellana, 261 Madrid, Spain |
Principal Investigator: | Josep Ramon Germà, MD | Institut Català d'Oncologia (ICO), Barcelona, Spain |
Principal Investigator: | Bozena Birkenfeld, MD | Medical University,1 Uni Lubelskiej Str., 71-242 Szczecin, Poland |
Principal Investigator: | Andrzej Kolodziejczyk, MD | Military Hospital, 5 Weigla Street, Wroclaw, Poland |
Principal Investigator: | Barbara Jarzab, MD | 15 Wybrzeze Armii Krajowej Street 44-101,Gliwice, Poland |
Principal Investigator: | Izabella Kozlowicz-Gudzińska, MD | National Medical Institute of Oncology (M. Skłodowska-Curie), 5 Roentgena Str 02-781, Warschau, Poland |
Principal Investigator: | Leszek Krolicki, MD | Medical Academy,University of Warschau, 1A Banacha Str 02-507 Warschau, Poland |
Principal Investigator: | Jerzy Sowiński, MD | Hospital of Medical Academy, 49 Przybyszewskiego Str, Poznań. Poland |
Principal Investigator: | Piotr Lass, MD | Institute of Radiology and Nuclear Medicine, 7 Debrinki Str., 80-211 Gdańsk, Poland |
Principal Investigator: | Ladislav Jarolim, MD | University Hospital Motol, V uvalu 84,Prague 5, 150 06, Czech Republic |
Principal Investigator: | David Felts, MD, PhD | University Hospital Ostrava, 17.listopadu 1790, Ostrava-Porub 708 52, Czech Republic |
Principal Investigator: | Ivan Pavlik, MD | General University Hospital, Ke Karlovu 6, Praha2 128 08, Czech Republic |
Principal Investigator: | Milan Hora, MD | University Hospital Plzen, E. Benese 13, Plzen 305 99, Czech Republic |
Principal Investigator: | Frantisek Zatura, MD | University Hospital Olomouc, I.P. Pavlova 6, Olomouc 775 20, Czech Republic |
Principal Investigator: | Ales Chodacki, MD | Hospital Chomutov, Kochova 1185, Chimutov 420 00, Czeck Republic |
Principal Investigator: | Ivo Kocak, MD | Masaryk Memorial Cancer Institute, Žlutý kopec 7, Brno 656 53, Czech Republic |
Principal Investigator: | Miroslav Krhovsky, MD | Hospital Kyjov, Urological Department, Strazovska 976, 697 33 Kyjov, Czech Republic |
Principal Investigator: | Isabelle Resche, MD | René Gauducheau, Nantes, France, Boulevard Jacques Monod, 44805 Saint-Herblain, NANTES cedex |
Principal Investigator: | Pierre Olivier, MD | CHU Nancy, Nancy, France, Médecine nucléaire - Avenue de Bourgogne, 54011 VANDOEUVRE LES NANCY |
Principal Investigator: | Pecking, MD | Centre René Huguenin, France, 35 Rue Dailly, 92210 SAINT-CLOUD |
Principal Investigator: | Vuillez, MD | CHU Michallon, Grenoble, France , Inserm 00-08, Service biophysique et médecine nucléaire, 38043 GRENOBLE Cedex |
Principal Investigator: | Mundler, MD | Hôpital de la Timone, Marseille, France, Médecine Nucléaire, 264 Rue Saint-Pierre, 13385 MARSEILLE cedex 05 |
Responsible Party: | Algeta ASA ( Thomas Ramdahl, President and Chief Executive Officer ) |
Study ID Numbers: | BC1-04 EudraCTno2005-003680-22 |
Study First Received: | June 13, 2006 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00337155 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; France: Afssaps - French Health Products Safety Agency |
Recurrent Prostate Cancer metastatic Cancer |
Signs and Symptoms Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |