246
Participants
Start Date
April 30, 2009
Primary Completion Date
September 30, 2011
Study Completion Date
September 30, 2011
Degarelix
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Bicalutamide
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.
University Urology Associates, New York
Premier Medical Group of Hudson, Baldwinsville
Hopital de la Timone, Marseille
Centre Francois Baclesse, Caen
"General Hospital of Athens, Sismanogleio, University of Athens, Marouse", Athens
Clinique Saint Brieuc, Saint-Brieuc
Urology of Virginia, Norfolk
Clinique Francheville, Périgueux
Hopital Jean Minjoz, Besançon
University General Hospital of Patras, Pátrai
Hospital Universitario La Paz, Madrid
Clinique du Parc, Toulouse
Institut Bergonié, Bordeaux
South Florida Medical Research, Aventura
Palm Beach Urology Associates, Wellington
Pinellas Urology Inc., St. Petersburg
DCT -Celebration, LLC dba Discovery Clinical Trials, Celebration
Alabama Research Center, Birmingham
Urology Centers of Alabama, Homewood
Urology Associates, Nashville
University General Hospital of Loannina, Medical School, Loannina
Fundación IVO, Valencia
Northeast Indiana Research, Fort Wayne
Summit Research Institute, Bloomington
Centre Oscar Lambret, Lille
Centre Paul Strauss, Strasbourg
General University Hospital of Alexandroupolis, Alexandroupoli
Centre Leon Berard, Lyon
Hôpital Tenon, Paris
Hôpital Saint Louis, Radiotherapy Departement, Paris
Centre de radiologie Saint Louis, Toulon
Arizona Urologic Specialists, Tuscon
CHU La Milétrie, Oncology Radiotherapy, Poitiers
Urology Group of New Mexico, Albuquerque
Tri-Valley Urology Medical Group, Murrieta
Orange County Urology, Lagua Hills
CHU Henri Mondor, Créteil
IGR, Villejuif
Alaska Urological Association, Anchorage
Connecticut Clinical Research Center, Middlebury
Urology Center Research Institute, Englewood
CRLC Val d'Aurelle Oncology Radiotherapy, Montpellier
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau, Saint-Herblain
Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie, Berlin
Städtisches Klinikum Braunschweig, Braunschweig
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie, Dresden
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie, Ulm
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk, Dordrecht
Groene Hart Ziekenhuis, urology, Gouda
Franciscus Gasthuis, Dept. urology, Rotterdam
Maastad Ziekenhuis, Ioc. Clara, Rotterdam
Vlietland Ziekenhuis, Dept. urology, Schiedam
St. Elisabeth Ziekenhuis Tilburg, Tilburg
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Universitari Vall d´Hebron, Barcelona
Kent Oncology Centre Maidstone Hospital, Maidstone
Mount Vernon Cancer Center, Northwood
Oncology Royal United Hospital Bath NHS Trust, Bath
Addenbrooke's Hospital, Oncology Centre, Cambridge
St. James' University Hospital, Leeds
The Royal Marsden NHS, Foundation Trust, London
Charing Cross Hospital, London
Northern Centre for Cancer Treatment, Newcastle General Hospital, Newcastle upon Tyne
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre, Southhampton
Velindre Hospital, Cardiff University, Whitchurch
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY