Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
NCT ID: NCT00884273
Last Updated: 2013-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2009-08-31
2011-03-31
Brief Summary
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The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.
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)
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
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 28 days after the first dose of goserelin.
Goserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, 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 28 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 0. The second and third doses of goserelin were administered on Days 28 and 56, 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 28 days after the first dose of goserelin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is 18 years or older
3. Patient has histologically confirmed prostate cancer
4. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL
5. The prostate size is \>30 cubic centimetres (cc), measured by TRUS
6. Patient has had a bone-scan within 12 weeks before inclusion
7. Patient must be able to undergo transrectal examinations
8. Patient has an estimated life expectancy of at least 12 months
Exclusion Criteria
2. Previous trans-urethral resection of the prostate (TURP)
3. Is not considered a candidate for medical castration
4. Use of urethral catheter
5. Is currently treated with a 5-alpha reductase inhibitor
6. Is currently treated with an alpha-adrenoceptor antagonist
7. Treatment with botulinum toxin A (Botox)
8. Require radiotherapy during the trial
9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
10. Hypersensitivity towards any component of the investigational products or excipients
11. Previous history or presence of another malignancy
12. A clinically significant disorder
13. A corrected QT interval over 450 msec
14. Mental incapacity or language barrier precluding adequate understanding or co-operation
15. Receipt of an investigational drug within the last 28 days proceeding screening
16. Previous participation in any degarelix trial
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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Hospital St Jan Brugge
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
University Hospitals Leuven
Leuven, , Belgium
St. Elisabethziekenhuis
Turnhout, , Belgium
Aalborg Sygehus syd
Aalborg, , Denmark
Århus Universitetshospital, Skejby
Aarhus, , Denmark
Herlev Hospital
Ballerup Municipality, , Denmark
Regionhospitalet Holstebro
Holstebro, , Denmark
Sygehus Syd, Næstved Sygehus
Næstved, , Denmark
Roskilde Sygehus
Roskilde, , Denmark
HYKS/kirurgian klin./urologia
Helsinki, , Finland
KYS/kirurgian klin (Kuopio)
Kuopio, , Finland
OYS/kirurgian klinik
Oulu, , Finland
TAYS/kirurgian klinik
Tampere, , Finland
Azienda Ospedaliero Universitaria Ospedali riuniti
Ancona, , Italy
Azienda Ospedaliera S. Giuseppe Moscaaati
Avellino, , Italy
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
Bologna, , Italy
U.O. Di Urologia - Spedali Civili di Brescia
Brescia, , Italy
Clinica Urologica 1 Universita. Firensa
Florence, , Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
Palermo, , Italy
Clinica Urologica - Azienda Ospedaliera di Perugia
Perugia, , Italy
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
Roma, , Italy
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
Torino, , Italy
Moelv spesialistsenter
Moelv, , Norway
Aker Universitetssykehus HF
Oslo, , Norway
Det Norske Radiumhospitalet HF
Oslo, , Norway
St Olavs Hospital HF
Trondheim, , Norway
Hospital Fernando da Fonseca
Amadora, , Portugal
Hospitais Universidade Coimbra
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
Lisbon, , Portugal
Hospital S.João
Porto, , Portugal
Investigational site
Gothenburg, , Sweden
SU/Sahlgrenska
Gothenburg, , Sweden
Helsingborgs Lasarett
Helsingborg, , Sweden
Universitetssjukhuset MAS
Malmo, , Sweden
Södertälje Sjukhus
Södertälje, , Sweden
Uppsala/Akademiska sjukhuset
Uppsala, , Sweden
Cerrahpasa Faculty of Medicine, Kocamustafapasa
Istanbul, , Turkey (Türkiye)
Istanbul University Faculty of Medicine, ÇAPA
Istanbul, , Turkey (Türkiye)
Marmara University Faculty of Medicine, Altunizade
Istanbul, , Turkey (Türkiye)
Ankara University Faculty of Medicine
Sıhhıye - Ankara, , Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Sıhhıye - Ankara, , Turkey (Türkiye)
Countries
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References
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Axcrona K, Aaltomaa S, da Silva CM, Ozen H, Damber JE, Tanko LB, Colli E, Klarskov P. Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide. BJU Int. 2012 Dec;110(11):1721-8. doi: 10.1111/j.1464-410X.2012.11107.x. Epub 2012 Apr 13.
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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2008-008604-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FE200486 CS31
Identifier Type: -
Identifier Source: org_study_id