Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT ID: NCT00833248
Last Updated: 2012-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2009-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Degarelix 240 mg/80 mg
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.
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 (3.6 mg) + bicalutamide (50 mg)
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).
On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria
* Previous trans-urethral resection of the prostate
* Patients who are lymph node positive or have other metastatic disease
* Use of urethral catheter
* Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Hypersensitivity towards any component of the investigational product
* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
18 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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
Baldwinsville, 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
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
CHU Henri Mondor
Créteil, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital de la Timone
Marseille, , France
CRLC Val d'Aurelle Oncology Radiotherapy
Montpellier, , France
Hôpital Tenon
Paris, , France
Hôpital Saint Louis, Radiotherapy Departement
Paris, , France
Clinique Francheville
Périgueux, , France
CHU La Milétrie, Oncology Radiotherapy
Poitiers, , France
Clinique Saint Brieuc
Saint-Brieuc, , France
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
Saint-Herblain, , France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , 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
Alexandroupoli, , 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
Pátrai, , 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
Countries
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References
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Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17.
Other Identifiers
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2008-005232-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FE200486 CS30
Identifier Type: -
Identifier Source: org_study_id