Spots Global Cancer Trial Database for European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
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Trial Identification
Brief Title: European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
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. Post Study 5-year Follow-up
Study ID: NCT04017325
Conditions
Interventions
Study Description
Brief Summary: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study
Detailed Description: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied. All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study. This extension study consists of 2 different follow-up: * a follow-up of patients via investigators * and a follow-up via interviews directly with patients
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Department of Urology-Tampere University Hospital-, Tampere, , Finland
Centre Hospitalier Universitaire (CHU), Angers, , France
CHRU Hopital Jean Minjoz, Besançon, , France
Site Médipole, Cabestany, , France
Polyclinique Sévigné, Cesson Sévigné, , France
Hôpital Claude Huriez, Lille, , France
Hôpital La Conception, Marseille, , France
Institut Mutualiste Montsouris (IMM), Paris Cedex 14, , France
Hôpital Cochin, Paris Cedex 14, , France
Hôpital Tenon, Paris, , France
Centre Hospitalier Universitaire Lyon Sud, Pierre-Bénite, , France
CHU Pontchaillou, Rennes, , France
Clinique Urologique Nantes, Saint Herblain, , 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
Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia, Torino, , Italy
Netherlands Cancer Institute, Amsterdam, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Hospital Universitario de A Coruña, A Coruña, , Spain
Department of Urology-Hospital Clinic, University of Barcelona, Barcelona, , Spain
Complejo Hospitalario Regional Virgen Del Rocio-Department Urology, Sevilla, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Dept of Urology-University Hospital-, Malmö, , Sweden
Kings College Hospital (KCH), London, , United Kingdom
University College London Hospital (UCLH), 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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