Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00884273
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 182
- Patient has given written informed consent
- Patient is 18 years or older
- Patient has histologically confirmed prostate cancer
- Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL
- The prostate size is >30 cubic centimetres (cc), measured by TRUS
- Patient has had a bone-scan within 12 weeks before inclusion
- Patient must be able to undergo transrectal examinations
- Patient has an estimated life expectancy of at least 12 months
- Any previous treatments for prostate cancer
- Previous trans-urethral resection of the prostate (TURP)
- Is not considered a candidate for medical castration
- Use of urethral catheter
- Is currently treated with a 5-alpha reductase inhibitor
- Is currently treated with an alpha-adrenoceptor antagonist
- Treatment with botulinum toxin A (Botox)
- Require radiotherapy during the trial
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
- Hypersensitivity towards any component of the investigational products or excipients
- Previous history or presence of another malignancy
- A clinically significant disorder
- A corrected QT interval over 450 msec
- Mental incapacity or language barrier precluding adequate understanding or co-operation
- Receipt of an investigational drug within the last 28 days proceeding screening
- Previous participation in any degarelix trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix 240 mg/80 mg 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 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 (3.6 mg) + bicalutamide (50 mg) Bicalutamide 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) After treatment of 12 weeks compared to Baseline TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) After treatment of 12 weeks compared to Baseline TRUS is a method of measuring the size of the prostate.
- Secondary Outcome Measures
Name Time Method Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study At 4, 8, and 12 weeks compared to baseline. Change in Serum Testosterone Levels During the Study At 4, 8, and 12 weeks compared to baseline. Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit After treatment of 4, 8, and 12 weeks compared to Baseline The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) After treatment of 4, 8, and 12 weeks compared to Baseline The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 After treatment of 4 and 8 weeks compared to Baseline TRUS is a method of measuring the size of the prostate.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 After treatment of 4, 8, and 12 weeks compared to Baseline The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Baseline to 12 weeks of treatment This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables Baseline to 12 weeks of treatment The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Trial Locations
- Locations (46)
Azienda Ospedaliero Universitaria Ospedali riuniti
🇮🇹Ancona, Italy
Institut Jules Bordet
🇧🇪Bruxelles, Belgium
KYS/kirurgian klin (Kuopio)
🇫🇮Kuopio, Finland
Moelv spesialistsenter
🇳🇴Moelv, Norway
SU/Sahlgrenska
🇸🇪Göteborg, Sweden
Hospitais Universidade Coimbra
🇵🇹Coimbra, Portugal
Istanbul University Faculty of Medicine, ÇAPA
🇹🇷Istanbul, Turkey
Ankara University Faculty of Medicine
🇹🇷Sıhhıye - Ankara, Turkey
Herlev Hospital
🇩🇰Ballerup, Denmark
Regionhospitalet Holstebro
🇩🇰Holstebro, Denmark
Sygehus Syd, Næstved Sygehus
🇩🇰Næstved, Denmark
Helsingborgs Lasarett
🇸🇪Helsingborg, Sweden
Hospital St Jan Brugge
🇧🇪Brugge, Belgium
University Hospitals Leuven
🇧🇪Leuven, Belgium
Aalborg Sygehus syd
🇩🇰Aalborg, Denmark
Roskilde Sygehus
🇩🇰Roskilde, Denmark
Ã…rhus Universitetshospital, Skejby
🇩🇰Århus, Denmark
OYS/kirurgian klinik
🇫🇮Oulu, Finland
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
🇮🇹Bologna, Italy
U.O. Di Urologia - Spedali Civili di Brescia
🇮🇹Brescia, Italy
TAYS/kirurgian klinik
🇫🇮Tampere, Finland
Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹Milano, Italy
Azienda Ospedaliera S. Giuseppe Moscaaati
🇮🇹Avellino, Italy
Clinica Urologica 1 Universita. Firensa
🇮🇹Firenze, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
🇮🇹Palermo, Italy
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
🇮🇹Roma, Italy
Clinica Urologica - Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
🇮🇹Torino, Italy
Hospital Fernando da Fonseca
🇵🇹Amadora, Portugal
Investigational site
🇸🇪Göteborg, Sweden
Södertälje Sjukhus
🇸🇪Södertälje, Sweden
Uppsala/Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Universitetssjukhuset MAS
🇸🇪Malmö, Sweden
Cerrahpasa Faculty of Medicine, Kocamustafapasa
🇹🇷Istanbul, Turkey
Marmara University Faculty of Medicine, Altunizade
🇹🇷Istanbul, Turkey
Hacettepe University Faculty of Medicine
🇹🇷Sıhhıye - Ankara, Turkey
HYKS/kirurgian klin./urologia
🇫🇮Helsinki, Finland
St Olavs Hospital HF
🇳🇴Trondheim, Norway
Aker Universitetssykehus HF
🇳🇴Oslo, Norway
Det Norske Radiumhospitalet HF
🇳🇴Oslo, Norway
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
🇵🇹Lisboa, Portugal
St. Elisabethziekenhuis
🇧🇪Turnhout, Belgium
Hospital S.João
🇵🇹Porto, Portugal