Prostate CancerPhase 3NCT00884273
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 46 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix, Goserelin and Bicalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 46 sitesin 8 countries
- Study dates
- Aug 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
Italy13 sites
Azienda Ospedaliero Universitaria Ospedali riuniti
Ancona
Azienda Ospedaliera S. Giuseppe Moscaaati
Avellino
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
Bologna
U.O. Di Urologia - Spedali Civili di Brescia
Brescia
Clinica Urologica 1 Universita. Firensa
Florence
Fondazione IRCCS Istituto Nazionale Tumori
Milan
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milan
Azienda Ospedaliera Universitaria Federico II
Naples
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
Palermo
Clinica Urologica - Azienda Ospedaliera di Perugia
Perugia
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
Roma
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
Torino
Denmark6 sites
Aalborg Sygehus syd
Aalborg
Århus Universitetshospital, Skejby
Aarhus
Herlev Hospital
Ballerup Municipality
Regionhospitalet Holstebro
Holstebro
Sygehus Syd, Næstved Sygehus
Næstved
Roskilde Sygehus
Roskilde
Sweden6 sites
Investigational site
Gothenburg
SU/Sahlgrenska
Gothenburg
Helsingborgs Lasarett
Helsingborg
Universitetssjukhuset MAS
Malmö
Södertälje Sjukhus
Södertälje
Uppsala/Akademiska sjukhuset
Uppsala
Turkey (Türkiye)5 sites
Cerrahpasa Faculty of Medicine, Kocamustafapasa
Istanbul
Istanbul University Faculty of Medicine, ÇAPA
Istanbul
Marmara University Faculty of Medicine, Altunizade
Istanbul
Ankara University Faculty of Medicine
Sıhhıye - Ankara
Hacettepe University Faculty of Medicine
Sıhhıye - Ankara
Belgium4 sites
Hospital St Jan Brugge
Bruges
Institut Jules Bordet
Brussels
University Hospitals Leuven
Leuven
St. Elisabethziekenhuis
Turnhout
Finland4 sites
HYKS/kirurgian klin./urologia
Helsinki
KYS/kirurgian klin (Kuopio)
Kuopio
OYS/kirurgian klinik
Oulu
TAYS/kirurgian klinik
Tampere
Norway4 sites
Moelv spesialistsenter
Moelv
Aker Universitetssykehus HF
Oslo
Det Norske Radiumhospitalet HF
Oslo
St Olavs Hospital HF
Trondheim
Portugal4 sites
Hospital Fernando da Fonseca
Amadora
Hospitais Universidade Coimbra
Coimbra
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
Lisbon
Hospital S.João
Porto
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Goserelin, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called FE200486, FIRMAGON
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.
GoserelinDrug
Also called ZOLADEX
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.
BicalutamideDrug
Also called CASODEX
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.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 240 mg/80 mg | Experimental | 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. Receives: Drug: Degarelix |
| Goserelin (3.6 mg) + bicalutamide (50 mg) | Active comparator | 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. Receives: Drug: Goserelin; Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
TRUS is a method of measuring the size of the prostate.
Measured: After treatment of 12 weeks compared to Baseline
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
TRUS is a method of measuring the size of the prostate.
Measured: After treatment of 12 weeks compared to Baseline
Secondary outcomes (8)
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
TRUS is a method of measuring the size of the prostate.
Measured: After treatment of 4 and 8 weeks compared to Baseline
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
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.
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change in Serum Testosterone Levels During the Study
Measured: At 4, 8, and 12 weeks compared to baseline.
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Measured: At 4, 8, and 12 weeks compared to baseline.
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
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').
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
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.
Measured: After treatment of 4, 8, and 12 weeks compared to Baseline
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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.
Measured: Baseline to 12 weeks of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
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.
Measured: Baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884273
- Sponsor's protocol ID
- FE200486 CS31
- Other IDs
- 2008-008604-40, 2008
- Status last verified
- Oct 2013
- First submitted
- 17 Apr 2009
- Last updated
- 13 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22500884Zengerling 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.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00884273
- Acronym / sponsor ID
- FE200486 CS31
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 11 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix 240 mg/80 mg | Experimental | Drug: DegarelixThe 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) | Active comparator | Drug: Goserelin, Drug: BicalutamideGoserelin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DegarelixAlso: FE200486, FIRMAGONThe 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. | Drug | Degarelix 240 mg/80 mg |
| GoserelinAlso: ZOLADEXGoserelin 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. | Drug | Goserelin (3.6 mg) + bicalutamide (50 mg) |
| BicalutamideAlso: CASODEXOn 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. | Drug | Goserelin (3.6 mg) + bicalutamide (50 mg) |
Primary outcome
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
Time frame: 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)
Time frame: After treatment of 12 weeks compared to Baseline
TRUS is a method of measuring the size of the prostate.
8 secondary outcomes
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
Time frame: After treatment of 4 and 8 weeks compared to Baseline
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change in Serum Testosterone Levels During the Study
Time frame: At 4, 8, and 12 weeks compared to baseline.
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time frame: At 4, 8, and 12 weeks compared to baseline.
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: Baseline to 12 weeks of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: Baseline to 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22500884Axcrona 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.
- Derived from this study: PubMed 34350976Zengerling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix, Goserelin and Bicalutamide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Italy, Denmark, Sweden, Turkey (Türkiye), Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (time frame: After treatment of 12 weeks compared to Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.