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Spots Global Cancer Trial Database for A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

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Trial Identification

Brief Title: A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

Official Title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

Study ID: NCT00967018

Conditions

Prostate Cancer

Interventions

Degarelix

Study Description

Brief Summary: Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Institut Jules Bordet, Bruxelles, , Belgium

St. Elisabethziekenhuis, Turnhout, , Belgium

Hopital Jean Minjoz, Besancon, , France

Institut Bergonié, Bordeaux Cedex, , France

Centre Francois Baclesse, Caen, , France

CHU Henri Mondor, Creteil, , France

Centre Oscar Lambret, Lille, , France

Centre Leon Berard, Lyon, , France

Hopital de la Timone, Marseille, Cedex, , France

CRLC Val d' Aurelle - Oncology Radiotherapy, Montpellier, , France

Hôpital Saint Louis - Radiotherapy Departement, Paris, , France

Hôpital Tenon, Paris, , France

Clinique Francheville, Perigueux, , France

CHU La Milétrie - Oncology Radiotherapy, Poitiers, , France

Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau, Saint Herblain Cedex, , France

Institut de Cancérologie de la Loire, Saint Priest en Jarez, , France

Clinique Saint Brieuc, St Brieuc Cedex, , France

Centre Paul Strauss, Strassbourg, , France

Centre de radiologie Saint Louis, Toulon, , France

Clinique du Parc, Toulouse, , France

IGR, Villejuif, , France

Azienda Ospedaliero Universitaria Ospedali riuniti, Ancona, , Italy

Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna, Bologna, , Italy

Clinica Urologica 1 Universita Firenze, Firenze, , Italy

Fondazione IRCCS Istituto Nazionale Tumori, Milano, , Italy

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, Milano, , Italy

Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo, Palermo, , Italy

Clinica Urologica - Azienda Ospedaliera di Perugia, Perugia, , Italy

Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma, Roma, , Italy

S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette, Torino, , Italy

Hospital Fernando da Fonseca, Amadora, , Portugal

Hospitais Universidade Coimbra, Coimbra, , Portugal

Centro Hospitalar Lisboa Norte, Hospital Santa Maria, Lisboa, , Portugal

Hospital S.João, Porto, , Portugal

Hospital Universitario Principe de Asturias, Alcalá de Henares-Madrid, , Spain

Fundacion Hospital Alcorcón, Alcorcon, , Spain

Fundación Puigvert, Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Hospital Universitari Vall d´Hebron, Barcelona, , Spain

Hospital de Basurto, Bilbao, , Spain

Hospital Clinico Universitario S. Carlos, Madrid, , Spain

Hospital Doce de Octubre, Madrid, , Spain

Hospital universitario Ramón y Cajal, Madrid, , Spain

Hospital Universitario Puerta de Hierro, Majadahonda, , Spain

Hospital Manacor, Manacor, , Spain

Hospital Universitario Central de Asturias, Oviedo, , Spain

Hospital Santiago de Compostela, Santiago de Compostela, , Spain

Hospital Virgen Macarena, Sevilla, , Spain

Fundación IVO, Valencia, , Spain

Hospital Xeral de Vigo, Vigo, , Spain

Investigational site, Göteborg, , Sweden

SU/Sahlgrenska, Göteborg, , Sweden

Helsingborgs Lasarett, Helsingborg, , Sweden

Universitetssjukhuset MAS, Malmö, , Sweden

Södertälje Sjukhus, Södertälje, , Sweden

Uppsala/Akademiska sjukhuset, Uppsala, , Sweden

Ankara University Faculty of Medicine - Sıhhıye, Ankara, , Turkey

Cerrahpasa Faculty of Medicine - Kocamustafapasa, Istanbul, , Turkey

Istanbul University Faculty of Medicine - ÇAPA, Istanbul, , Turkey

Marmara University Faculty of Medicine - Altunizade, Istanbul, , Turkey

Contact Details

Name: Clinical Development Support

Affiliation: Ferring Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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