Spots Global Cancer Trial Database for Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
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Trial Identification
Brief Title: Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Official Title: A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration
Study ID: NCT00884273
Conditions
Study Description
Brief Summary: This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Hospital St Jan Brugge, Brugge, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
University Hospitals Leuven, Leuven, , Belgium
St. Elisabethziekenhuis, Turnhout, , Belgium
Aalborg Sygehus syd, Aalborg, , Denmark
Herlev Hospital, Ballerup, , Denmark
Regionhospitalet Holstebro, Holstebro, , Denmark
Sygehus Syd, Næstved Sygehus, Næstved, , Denmark
Roskilde Sygehus, Roskilde, , Denmark
Århus Universitetshospital, Skejby, Århus, , Denmark
HYKS/kirurgian klin./urologia, Helsinki, , Finland
KYS/kirurgian klin (Kuopio), Kuopio, , Finland
OYS/kirurgian klinik, Oulu, , Finland
TAYS/kirurgian klinik, Tampere, , Finland
Azienda Ospedaliero Universitaria Ospedali riuniti, Ancona, , Italy
Azienda Ospedaliera S. Giuseppe Moscaaati, Avellino, , Italy
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna, Bologna, , Italy
U.O. Di Urologia - Spedali Civili di Brescia, Brescia, , Italy
Clinica Urologica 1 Universita. Firensa, 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
Moelv spesialistsenter, Moelv, , Norway
Aker Universitetssykehus HF, Oslo, , Norway
Det Norske Radiumhospitalet HF, Oslo, , Norway
St Olavs Hospital HF, Trondheim, , Norway
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
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
Cerrahpasa Faculty of Medicine, Kocamustafapasa, Istanbul, , Turkey
Istanbul University Faculty of Medicine, ÇAPA, Istanbul, , Turkey
Marmara University Faculty of Medicine, Altunizade, Istanbul, , Turkey
Ankara University Faculty of Medicine, Sıhhıye - Ankara, , Turkey
Hacettepe University Faculty of Medicine, Sıhhıye - Ankara, , Turkey
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
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