Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
NCT ID: NCT00831233
Last Updated: 2013-11-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
42 participants
INTERVENTIONAL
2009-04-30
2010-07-31
Brief Summary
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Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
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
Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
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)
Goserelin (3.6 mg) + bicalutamide (50 mg)
Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Bicalutamide
On Day 0, three days before the first dose of goserelin on Day 3, patients 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 second and third doses of goserelin were administered on Days 31 and 59, respectively.
Bicalutamide
On Day 0, three days before the first dose of goserelin on Day 3, patients 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
* Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
* 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)
* 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.
* 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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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Facharztpraxis für Urologie
Bamberg, , Germany
Gemeinschaftspraxis
Borken, , Germany
Gemeinschaftspraxis
Cologne, , Germany
Universitätsklinikum Dresden
Dresden, , Germany
Euromed Clinic
Fürth, , Germany
Urologische Gemeinschaftspraxis
Hamburg, , Germany
VITURO Gesellschaft für Klinische Studien
Leipzig, , Germany
Klinikum Offenbach GmbH
Offenbach, , Germany
Urologische Klinik Planegg
Planegg, , Germany
Wuppertaler Gemeinschaftspraxis
Wuppertal, , Germany
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares-Madrid, , Spain
Fundacion Hospital Alcorcón
Alcorcón, , Spain
Fundación Puigvert
Barcelona, , Spain
Hospital de Basurto
Bilbao (Bizkaia), , Spain
Hospital universitario Ramón y Cajal
Madrid, , Spain
Hospital Clinico Universitario S. Carlos
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, , Spain
Hospital Manacor
Manacor, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Virgen Macarena
Seville, , Spain
Hospital Xeral de Vigo
Vigo, , Spain
United Bristol Healthcare NHSTrust Bristol Royal Infirmary
Bristol, , United Kingdom
Falkirk and District Royal Infirmary
Falkirk, , United Kingdom
Southern General Hospital
Glasgow, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Whipps Cross University Hospital
London, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Royal Hallamshire Hospital, Sheffield South
Sheffield, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Countries
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References
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Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15.
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.
Other Identifiers
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2008-004338-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FE200486 CS28
Identifier Type: -
Identifier Source: org_study_id