Spots Global Cancer Trial Database for Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
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Trial Identification
Brief Title: Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Official Title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Study ID: NCT00833248
Conditions
Study Description
Brief Summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Alabama Research Center, Birmingham, Alabama, United States
Urology Centers of Alabama, Homewood, Alabama, United States
Alaska Urological Association, Anchorage, Alaska, United States
Arizona Urologic Specialists, Tuscon, Arizona, United States
Orange County Urology, Lagua Hills, California, United States
Tri-Valley Urology Medical Group, Murrieta, California, United States
Connecticut Clinical Research Center, Middlebury, Connecticut, United States
South Florida Medical Research, Aventura, Florida, United States
DCT -Celebration, LLC dba Discovery Clinical Trials, Celebration, Florida, United States
Pinellas Urology Inc., St. Petersburg, Florida, United States
Palm Beach Urology Associates, Wellington, Florida, United States
Summit Research Institute, Bloomington, Indiana, United States
Northeast Indiana Research, Fort Wayne, Indiana, United States
Urology Center Research Institute, Englewood, New Jersey, United States
Urology Group of New Mexico, Albuquerque, New Mexico, United States
Premier Medical Group of Hudson, Columbia, New York, United States
University Urology Associates, New York, New York, United States
Urology Associates, Nashville, Tennessee, United States
Urology of Virginia, Norfolk, Virginia, United States
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 5, , France
CRLC Val d'Aurelle Oncology Radiotherapy, Montpellier, , France
Hôpital Tenon, Paris, , France
Hôpital Saint Louis, Radiotherapy Departement, 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
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie, Berlin, , Germany
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie, Dresden, , Germany
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie, Ulm, , Germany
General University Hospital of Alexandroupolis, Alexandroupolis, , Greece
General Hospital of Athens, "Sismanogleio", University of Athens, Marouse, Athens, , Greece
University General Hospital of Loannina, Medical School, Loannina, , Greece
University General Hospital of Patras, Patras, , Greece
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk, Dordrecht, , Netherlands
Groene Hart Ziekenhuis, urology, Gouda, , Netherlands
Franciscus Gasthuis, Dept. urology, Rotterdam, , Netherlands
Maastad Ziekenhuis, Ioc. Clara, Rotterdam, , Netherlands
Vlietland Ziekenhuis, Dept. urology, Schiedam, , Netherlands
St. Elisabeth Ziekenhuis Tilburg, Tilburg, , Netherlands
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d´Hebron, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Fundación IVO, Valencia, , Spain
Kent Oncology Centre Maidstone Hospital, Maidstone, Kent, United Kingdom
Mount Vernon Cancer Center, Northwood, Middlesex, United Kingdom
Oncology Royal United Hospital Bath NHS Trust, Bath, , United Kingdom
Addenbrooke's Hospital, Oncology Centre, Cambridge, , United Kingdom
St. James' University Hospital, Leeds, , United Kingdom
The Royal Marsden NHS, Foundation Trust, London, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
Northern Centre for Cancer Treatment, Newcastle General Hospital, Newcastle upon Tyne, , United Kingdom
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre, Southhampton, , United Kingdom
Velindre Hospital, Cardiff University, Whitchurch, , United Kingdom
Contact Details
Name: Clinical Development Support
Affiliation: Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
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