Clinical trial NCT00884273: Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Official title: A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Volume Reduction of the Prostate in Patients With Prostate Cancer Being Candidates for Medical Castration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 182
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.

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.


Eligibility criteria: Inclusion Criteria:

1. Patient has given written informed consent
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:

1. Any previous treatments for prostate cancer
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

Primary outcomes:
measure: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
timeFrame: After treatment of 12 weeks compared to Baseline
measure: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
timeFrame: After treatment of 12 weeks compared to Baseline
Secondary outcomes:
measure: Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
timeFrame: After treatment of 4 and 8 weeks compared to Baseline
measure: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Change in Serum Testosterone Levels During the Study
timeFrame: At 4, 8, and 12 weeks compared to baseline.
measure: Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
timeFrame: At 4, 8, and 12 weeks compared to baseline.
measure: Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
timeFrame: After treatment of 4, 8, and 12 weeks compared to Baseline
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Baseline to 12 weeks of treatment
measure: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
timeFrame: Baseline to 12 weeks of treatment
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Hospital St Jan Brugge
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Turnhout
country: Belgium
facility: St. Elisabethziekenhuis
city: Aalborg
country: Denmark
facility: Aalborg Sygehus syd
city: Ballerup
country: Denmark
facility: Herlev Hospital
city: Holstebro
country: Denmark
facility: Regionhospitalet Holstebro
city: Næstved
country: Denmark
facility: Sygehus Syd, Næstved Sygehus
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Århus
country: Denmark
facility: Århus Universitetshospital, Skejby
city: Helsinki
country: Finland
facility: HYKS/kirurgian klin./urologia
city: Kuopio
country: Finland
facility: KYS/kirurgian klin (Kuopio)
city: Oulu
country: Finland
facility: OYS/kirurgian klinik
city: Tampere
country: Finland
facility: TAYS/kirurgian klinik
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali riuniti
city: Avellino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscaaati
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
city: Brescia
country: Italy
facility: U.O. Di Urologia - Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Clinica Urologica 1 Universita. Firensa
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
city: Perugia
country: Italy
facility: Clinica Urologica - Azienda Ospedaliera di Perugia
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
city: San Giovanni Rotondo
country: Italy
facility: S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
city: Moelv
country: Norway
facility: Moelv spesialistsenter
city: Oslo
country: Norway
facility: Aker Universitetssykehus HF
city: Oslo
country: Norway
facility: Det Norske Radiumhospitalet HF
city: Trondheim
country: Norway
facility: St Olavs Hospital HF
city: Amadora
country: Portugal
facility: Hospital Fernando da Fonseca
city: Coimbra
country: Portugal
facility: Hospitais Universidade Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, Hospital Santa Maria
city: Porto
country: Portugal
facility: Hospital S.João
city: Göteborg
country: Sweden
facility: Investigational site
city: Göteborg
country: Sweden
facility: SU/Sahlgrenska
city: Helsingborg
country: Sweden
facility: Helsingborgs Lasarett
city: Malmö
country: Sweden
facility: Universitetssjukhuset MAS
city: Södertälje
country: Sweden
facility: Södertälje Sjukhus
city: Uppsala
country: Sweden
facility: Uppsala/Akademiska sjukhuset
city: Istanbul
country: Turkey
facility: Cerrahpasa Faculty of Medicine, Kocamustafapasa
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine, ÇAPA
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine, Altunizade
city: Sıhhıye - Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
city: Sıhhıye - Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.