Prostate CancerPhase 3NCT01242748
A Degarelix Trial in Patients With Prostate Cancer
A Phase 3 study testing Degarelix and Goserelin acetate in people with Prostate Cancer, run by Ferring Pharmaceuticals at 63 sites in 13 countries.
Trial summary
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 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
- 288 participants
- Where
- 63 sitesin 13 countries
- Study dates
- Oct 2010to Jan 2012
- 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
- Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- Has completed the CS35 trial.
Who cannot join
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Trial locations and contacts
63 sites in 13 countries.
63 sites in 13 countries
Romania10 sites
Private Medical Center SRL
Arad
Brasov Emergency Clinical County Hospital
Brasov
"Prof. Dr. Th. Burghele" Clinical Hospital
Bucharest
"Sfantul Ioan" Emergency Clinical Hospital
Bucharest
Dinu Uromedica
Bucharest
Fundeni Clinical Institute of Uronephrology and Renal Transplantation
Bucharest
PROVITA 2000 Medical Center
Constanța
"Dr. C.I. Parhon" Clinical Hospital
Iași
Vita Care Flav Medical Center
Piteşti
Sibiu Emergency Clinical County Hospital
Sibiu
Hungary9 sites
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest
Semmelweis Egyetem
Budapest
Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
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
United States8 sites
Urology Group of New Mexico, PC
Albuquerque, New Mexico
University of Colorado School of Medicine
Aurora, Colorado
South Florida Medical Research
Aventura, Florida
Seattle Urology Research Center
Burien, Washington
The Urology Center of Colorado
Denver, Colorado
Urology Associates of Dover, PA
Dover, Delaware
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Urology San Antonio Research, Pa
San Antonio, Texas
Czechia6 sites
Urocentrum Brno
Brno
Nemocnice Jindrichuv Hradec, a.s.
Jindřichův Hradec
Kromerizska nemocnice a.s.
Kroměříž
Fakultni nemocnice v Motole, Praha 5
Prague
Vseobecna fakultni nemocnice v Praze, Praha 2
Prague
Krajska nemocnice T. Bati a.s.
Zlín
Mexico6 sites
Hospital Christus Muguerza del Parque
Chihuahua, Chih.
Hospital Angeles Culiacan
Culiacan, Sinaloa
Consultorio de Especialidad en Urologia Privado
Durango
Médica Sur, S.A.B. de C.V.
Mexico City
Hospital Angeles Lindavista
Mexico City, DF
Consultorio Medico
Zapopan, Jalisco
Ukraine6 sites
Dnipropetrovsk State Medical Academy
Dnipropetrovsk
Donetsk Regional Clinical Territorial Medical Association
Donetsk
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
Canada5 sites
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario
Southern Interior Medical Research Inc.
Kelowna
Mor Urology, Inc.
Newmarket
Investigational site
Scarborough
Investigational site
Toronto
Finland3 sites
ODL Terveys Oy
Oulu
Pohjois-Karjalan keskussairaala
Tampere
Tampereen yliopistollinen sairaala
Tampere
Poland3 sites
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
Bialystok
Centrum Medyczne Medur Sp. z o.o.
Bielsko-Biala
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Słupsk
Germany2 sites
Gemeinschaftspraxis Rudolph & Wörner
Kirchheim
Urologische Studienpraxis
Nürtingen
United Kingdom2 sites
Ipswich Hospital
Ipswich
The Royal Marsden NHS Foundation Trust
Sutton
About this study
Official title: An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Read the detailed description
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
- 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. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Goserelin acetateDrug
Also called Zoladex
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
| 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.
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
Measured: From baseline to 3 years
Secondary outcomes (7)
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.
Measured: From baseline to 3 years
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.
Measured: From baseline to 3 years
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.
Measured: From baseline to 3 years
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.
Measured: From baseline to 3 years
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.
Measured: From baseline to 3 years
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Measured: Baseline and after 1, 6, 12, 19, and 22 months
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Measured: Baseline and after 1, 6, 12, 19, and 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionJan 2012
Why it stopped: Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 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
- NCT01242748
- Sponsor's protocol ID
- FE200486 CS35A
- Other IDs
- 2010-021434-55
- Status last verified
- May 2015
- First submitted
- 16 Nov 2010
- Last updated
- 3 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT01242748
- Acronym / sponsor ID
- FE200486 CS35A
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Detailed description
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 (2 listed)
- Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- Has completed the CS35 trial.
Key exclusion criteria (2 listed)
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
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. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months. | Drug | Degarelix 240 mg/480 mg |
| Goserelin acetateAlso: ZoladexThe goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months. | Drug | Goserelin acetate |
Primary outcome
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
7 secondary outcomes
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
Time frame: From baseline to 3 years
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
Time frame: Baseline and after 1, 6, 12, 19, and 22 months
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
Time frame: Baseline and after 1, 6, 12, 19, and 22 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
63 sites in 13 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 63 sites in 13 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in Romania, Hungary, United States, Czechia, Mexico and 8 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 3 Jun 2015). 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?
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin (time frame: From baseline to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.