Prostate CancerPhase 3NCT00946920
A Trial of Degarelix in Patients With Prostate Cancer
A Phase 3 study testing Degarelix and Goserelin acetate in people with Prostate Cancer, run by Ferring Pharmaceuticals at 126 sites in 14 countries.
Trial summary
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer. 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 and Goserelin acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 859 participants
- Where
- 126 sitesin 14 countries
- Study dates
- Jun 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
- 18 years or older.
- Has a histological confirmed prostate cancer Gleason graded).
- Has a screening testosterone above 2.2 ng/mL.
- Rising prostate-specific antigen (PSA).
- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
- Has a life expectancy of at least one year.
Who cannot join
- Current or previous hormone therapy.
- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Has a heart insufficiency.
- Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
- Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
Trial locations and contacts
126 sites in 14 countries.
126 sites in 14 countries
United States36 sites
Capital Region Urological Surgeons and Research Associates
Albany, New York
Urology Group of New Mexico, PC
Albuquerque, New Mexico
Anschutz Cancer Pavillion
Aurora, Colorado
South Florida Medical Research
Aventura, Florida
Urologic Consultants of SEPA
Bala-Cynwyd, Pennsylvania
Seattle Urology Research Center
Burien, Washington
Metrolina Urology Clinic
Charlotte, North Carolina
Northeast Urology Research
Concord, North Carolina
Urology Clinics of North Texas, PA
Dallas, Texas
The Urology Center of Colorado
Denver, Colorado
Urology Associates of Dover, PA
Dover, Delaware
Duke University Medical Center
Durham, North Carolina
Urological Associates of Englewood
Englewood, New Jersey
Urology Associates of Central CA
Fresno, California
Alliance Urology Specialists
Greensboro, North Carolina
Hamilton Urology PA
Hamilton, New Jersey
Urology Centers Of Alabama
Homewood, Alabama
Indiana University Department of Urology
Indianapolis, Indiana
Medresearch
La Mesa, California
South Orange County Medical Research Center
Laguna Hills, California
Lawrenceville Urology
Lawrenceville, New Jersey
Arkansas Urology
Little Rock, Arkansas
Atlantic Urology Medical Group
Long Beach, California
Grand Strand Urology
Myrtle Beach, South Carolina
Urology of Virginia
Norfolk, Virginia
Florida Foundation for Healthcare Research
Ocala, Florida
Kansas City Urology Care, PA
Overland Park, Kansas
Hudson Valley Urology P.C.
Poughkeepsie, New York
Virginia Urology Center
Richmond, Virginia
Urology San Antonio Research
San Antonio, Texas
State College Urologic Association
State College, Pennsylvania
Urological Associates of Bridgeport, P.C.
Trumbull, Connecticut
Urology of Virginia
Virginia Beach, Virginia
Walter Reed Army Medical Center
Washington D.C., District of Columbia
Georgis Patsias, MD, PA
Wellington, Florida
Palm Beach Urology Associates, PA
Wellington, Florida
Canada13 sites
Bramalea Medical Centre
Brampton, Ontario
Southern Interior Medical Research Inc.
Kelowna, British Columbia
Urology Associates / Urologic Medical Research
Kitchener, Ontario
Uro Laval
Laval, Quebec
Notre Dame Hopital
Montreal
Mor Urology, Inc.
Newmarket, Ontario
Ivestigational site
Scarborough Village, Ontario
Dr. Cal Andreou Research
Surrey, British Columbia
Anthony Skehan Medicine Professionals Corporation
Thunder Bay, Ontario
Bloor West Professional Center
Toronto, Ontario
The Health Institute for Men
Toronto, Ontario
Can-Med Clinical Research Inc.
Victoria, British Columbia
Dr Gary Steinhoff Clinical Research
Victoria, British Columbia
Romania10 sites
Private Medical Center
Arad
Brasov Emergency Clinical County Hospital
Brasov
"Fundeni" Clinical Institute
Bucharest
"Sfantul Ioan" Emergency Clinical Hospital
Bucharest
Dinu Uromedica
Bucharest
Prof. Dr. Th. Burghele Clinical Urology Hospital
Bucharest
PROVITA 2000 Medical Center
Constanța
"Dr. C.I. Parhon" Clinical Hospital
Lasi
Vita Care Flav Medical Center
Piteşti
Emergency County Clinical Hospital Sibiu
Sibiu
Hungary9 sites
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest
Semmelweis Egyetem
Budapest
Dombóvári Szent Lukács Egészségügyi Kht.
Dombóvár
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
Miskolc
Pécsi Tudományegyetem
Pécs
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged
Jávorszky Ödön Kórház
Vác
Russia9 sites
City Clinical Hospital #60
Moscow
Moscow State University of Medicine and Dentistry
Moscow
"Clinic Andros" LLC
Saint Petersburg
"Orkli" LLC
Saint Petersburg
City Hospital # 26
Saint Petersburg
City Hospital #15
Saint Petersburg
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg
St.Petersburg Multi-Field City Hospital #2
Saint Petersburg
Regional Clinical Oncology Center
Vladimir
Czechia8 sites
Urocentrum Brno
Brno
Nemocnice Jindrichuv Hradec, a.s.
Jindřichův Hradec
Kromerizska nemocnice a.s.
Kroměříž
Slezska nemocnice
Opava
Fakultni nemocnice v Motole, Praha 5
Prague
Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
Prague
Vseobecna fakultni nemocnice v Praze, Praha 2
Prague
Krajska nemocnice T. Bati a.s.
Zlín
Mexico8 sites
Hospital Christus Muguerza del Parque
Chihuahua City, Chihuahua
Hospital Angeles Culiacan
Culiacán, Sinaloa
Consultorio de Especialidad en Urologia Privado, Durango
Durango
Hospital Aranda de la Parra , S.A. de C.V.
León, Guanajuato
Centro Medico Dalinde
Mexico City
Hospital Angeles Lindavista
Mexico City
Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
Mexico City
Consultorio Medico
Zapopan, Jalisco
Ukraine8 sites
Municipal Institution "Cherkasy Regional Oncology Dispensary"
Cherkassy
Dnipropetrovsk State Medical Academy
Dnipropetrovsk
Donetsk Regional Clinical Territorial Medical Association
Donetsk
Ivano-Frankivsk Regional Oncology Dispensary
Ivano-Frankivsk
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
Kharkiv
Kyiv City Clinical Hospital #3
Kyiv
Odesa Regional Clinical Hospital
Odesa
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
Zaporizhzhya
Poland5 sites
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
Bialystok
Centrum Medyczne Medur Sp. z o.o.
Bielsko-Biala
Gabinet Lekarski
Krakow
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Słupsk
LexMedica
Wroclaw
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels
UZ Antwerpen
Edegem
UZ Gent
Ghent
AZ Groeninge - Campus Sint-Maarten
Kortrijk
Finland4 sites
Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
Jakobstad
Pohjois-Karjalan keskussairaala
Joensuu
ODL Terveys Oy
Oulu
Tampereen yliopistollinen sairaala
Tampere
Germany4 sites
Investigational site
Aachen
Investigational site
Kirchheim
Klinikum Mannheim Universitätsklinikum GmbH
Mannheim
Urologische Studienpraxis
Nürtingen
Netherlands4 sites
AMC
Amsterdam
Catharina-ziekenhuis
Eindhoven
Atrium MC
Heerlen
MC Haaglanden
The Hague
United Kingdom4 sites
Castle Hill Hospital
Cottingham
Ipswich Hospital
Ipswich
Royal Liverpool University Hospital
Liverpool
The Royal Marsden NHS Foundation Trust
Sutton
About this study
Official title: An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Goserelin acetate
- 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 Firmagon, FE200486
The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin acetateDrug
Also called Zoladex
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 240 mg/480 mg | Experimental | Not described Receives: Drug: Degarelix |
| Goserelin acetate | Active comparator | Not described Receives: Drug: Goserelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Measured: From Day 28 to Day 364
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
Measured: Day 3 to Day 364
Secondary outcomes (4)
Serum Levels of Testosterone Over Time
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Measured: Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Measured: Baseline and after 1, 2, 3, 6 and 13 months
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Measured: At baseline, 10 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.
Measured: At baseline, 1 month, 4 months, 7 months and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJun 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 (1)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
- 859 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
- NCT00946920
- Sponsor's protocol ID
- FE200486 CS35
- Other IDs
- 2008-005276-27, 2008
- Status last verified
- May 2014
- First submitted
- 3 Jul 2009
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT00946920
- Acronym / sponsor ID
- FE200486 CS35
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 859 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
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/480 mg | Experimental | Drug: Degarelix |
| Goserelin acetate | Active comparator | Drug: Goserelin acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older.
- Has a histological confirmed prostate cancer Gleason graded).
- Has a screening testosterone above 2.2 ng/mL.
- Rising prostate-specific antigen (PSA).
- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
Key exclusion criteria (8 listed)
- Current or previous hormone therapy.
- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Has a heart insufficiency.
- Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
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: Firmagon, FE200486The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations). | Drug | Degarelix 240 mg/480 mg |
| Goserelin acetateAlso: ZoladexThe goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants). | Drug | Goserelin acetate |
Primary outcome
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
Time frame: From Day 28 to Day 364
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
Time frame: Day 3 to Day 364
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
4 secondary outcomes
Serum Levels of Testosterone Over Time
Time frame: Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Time frame: Baseline and after 1, 2, 3, 6 and 13 months
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
Time frame: At baseline, 10 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
Time frame: At baseline, 1 month, 4 months, 7 months and 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
126 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix and Goserelin acetate in people with Prostate Cancer, run by Ferring Pharmaceuticals at 126 sites in 14 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 6 inclusion and 8 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 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, Canada, Romania, Hungary, Russia and 9 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 2 Jun 2014). 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?
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix (time frame: From Day 28 to Day 364). 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 NCT00946920, which also lists 1 linked publication.
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 2 Jun 2014.