Spots Global Cancer Trial Database for Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
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Trial Identification
Brief Title: Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.
Official Title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance
Study ID: NCT01310894
Conditions
Interventions
Study Description
Brief Summary: The aims of this study are: * to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and * to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).
Detailed Description: This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy. Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Dept. of Urology-University Hospitals Leuven, Leuven, , Belgium
Department of Urology-Tampere University Hospital-, Tampere, , Finland
Service d'Urologie - Centre Hospitalier Universitaire d'Angers, Angers, , France
CHRU Hopital Jean Minjoz, Besançon, , France
Site Médipole, Cabestany, , France
Polyclinique Sévigné, Cesson Sévigné, , France
Clinique d'Urologie et de Transplantation Rénale CHU Grenoble, Grenoble, , France
Hôpital Claude Huriez, Lille, , France
Hôpital La Conception, Marseille, , France
Clinique Ambroise Paré, Neuilly sur Seine, , France
Institut Mutualiste Montsouris (IMM), Paris Cedex 14, , France
Hôpital Cochin, Paris Cedex 14, , France
Hôpital Tenon, Paris, , France
Institut Mutualiste Montsouris (IMM), Paris, , France
Centre Hospitalier Universitaire Lyon Sud, Pierre-Bénite, , France
Polyclinique les Bleuets, Reims, , France
CHU Pontchaillou, Rennes, , France
Clinique Urologique Nantes, Saint Herblain, , France
Hôpital Foch, Suresnes, , France
Centre Hospitalier Universitaire de Rangueil, Toulouse, , France
Marien Krankenahaus GmbH, Bergisch Gladbach, , Germany
ATURO-Gemeinschaftspraxis für Urologie und Andrologie, Berlin-Wilmersdorf, , Germany
Klinikum Braunschweig, Braunschweig, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität, Dresden, , Germany
Urologische Gemeinschaftspraxis, Emmendingen, , Germany
Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center, Hamburg, , Germany
Vinzenz Krankenhaus - Department of Urology, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
University Hospital Schleswig-Holstein, Kiel, , Germany
Ludwig-Maximilians-Universität München, Munich, , Germany
Urologie 24, Nuremberg, , Germany
Unità Operativa Urologia Lucca - c/o Azienda USL 2 - Ospedale Campo di Marte, Lucca, , Italy
Unità di Chirurgia Urologica Mininvasiva, Roma, , Italy
Unità Operativa Urologica di Savona, Ospedale San Paolo di Savona, Savona, , Italy
Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia, Torino, , Italy
Netherlands Cancer Institute, Amsterdam, , Netherlands
Polikliniek Urologie-Catharina Ziekenhuis, Eindhoven, , Netherlands
Hospital Universitari de Bellbitge-Servico de Urologia, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de A Coruña, A Coruña, , Spain
Fundacio Puigvert-Department of Urology, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Department of Urology-Hospital Clinic, University of Barcelona, Barcelona, , Spain
Hospital 12 de Octubre - Departmento de Urologia, Madrid, , Spain
Complejo Hospitalario Regional Virgen Del Rocio-Department Urology, Sevilla, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Dept of Urology-University Hospital-, Malmö, , Sweden
Anna-Seiler-Haus Inselspital, Bern, , Switzerland
Kings College Hospital (KCH), London, , United Kingdom
University College of London Hospital, London, , United Kingdom
Oxford John Radcliffe Hospital Trust, Oxford, , United Kingdom
Royal Hallamshire Hospital, Sheffield, , United Kingdom
Contact Details
Name: Mark Emberton, Professor
Affiliation: University College of London Hospital , United Kingdom
Role: PRINCIPAL_INVESTIGATOR
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