Spots Global Cancer Trial Database for A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
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Trial Identification
Brief Title: A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
Official Title: A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy
Study ID: NCT00378690
Conditions
Interventions
Study Description
Brief Summary: Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
, Brussel, , Belgium
, Bruxelles, , Belgium
, Bruxelles, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Bmo, , Czech Republic
, Jablonec nad Nisou, , Czech Republic
, Olomouc, , Czech Republic
, Usti nad Labem, , Czech Republic
, Joensuu, , Finland
, Tampere, , Finland
, Avignon, , France
, Bordeaux, , France
, Brest, , France
, Caen-Cedex, , France
, Cergy-Pontoise, , France
, Grenoble, , France
, Marseille, , France
, Nantes, , France
, Paris, , France
, Paris, , France
, Paris, , France
, Pierre-Benite, , France
, Ploemeur, , France
, Rouen, , France
, Suresnes, , France
, Toulon, , France
, Toulouse, , France
, Bad Neuenaher, , Germany
, Bautzen, , Germany
, Dresden, , Germany
, Dresden, , Germany
, Hagenow, , Germany
, Halle/Saale, , Germany
, Hettstedt, , Germany
, Leipzig, , Germany
, Neustadt i. Sachsen, , Germany
, Trier, , Germany
, Budapest, , Hungary
, Kaposvar, , Hungary
, Nyiregyhaza, , Hungary
, Szolnok, , Hungary
, Tatabanya, , Hungary
, Veszprem, , Hungary
, Desio, Milano, Italy
, Ancona, , Italy
, Bari, , Italy
, Bergamo, , Italy
, Bologna, , Italy
, Chieti, , Italy
, Messina, , Italy
, Milano, , Italy
, Parma, , Italy
, Roma, , Italy
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, St. Petersburg, , Russian Federation
, St. Petersburg, , Russian Federation
, Martin, , Slovakia
, Skalica, , Slovakia
, Trencin, , Slovakia
, Alcorcon, Madrid, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Granada, , Spain
, La Coruna, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Valencia, , Spain
Contact Details
Name: Central Contact
Affiliation: Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
Role: STUDY_DIRECTOR
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