Prostate CancerPhase 3NCT00451958
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
A Phase 3 study testing Degarelix 80 mg / Degarelix 80 mg, Degarelix 160 mg / Degarelix 160 mg and Leuprolide 7.5 mg / Degarelix 80 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 69 sites in 12 countries.
Trial summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years. 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 80 mg / Degarelix 80 mg, Degarelix 160 mg / Degarelix 160 mg and Leuprolide 7.5 mg / Degarelix 80 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 69 sitesin 12 countries
- Study dates
- Mar 2007to Dec 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
- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Signed informed consent
- The patients must have completed the FE 200486 CS21 Study.
Who cannot join
None listed.
Trial locations and contacts
69 sites in 12 countries.
69 sites in 12 countries
United States14 sites
South Florida Medical Research
Aventura, Florida
Seattle Urology Research Center
Burien, Washington
Investigational Site
Carmel, New York
North Urology Research
Concord, North Carolina
Urology Associates Research
Englewood, Colorado
Investigational Site
Greensboro, North Carolina
Urology Centers Of Alabama
Homewood, Alabama
South Orange County Medical Research Center
Laguna Hills, California
Lawrenceville Urology
Lawrenceville, New Jersey
Investigational Site
Ocala, Florida
Urology San Antonio Research
San Antonio, Texas
Regional Urology
Shreveport, Louisiana
State College Urologic Association
State College, Pennsylvania
Western Clinical Research
Torrance, California
Canada9 sites
The Female/Male Health Centres
Barrie, Ontario
Brantford Urology Research
Brantford, Ontario
Burlington Professional Centre
Burlington, Ontario
The Urology Research Centre
Burlington, Ontario
Urology South Shore Research
Greenfields, Quebec
Investigational Site
Kentville, Nova Scotia
Investigational Site
Newmarket, Ontario
The Female/Male Health Centres
Oakville, Ontario
Can-Med Clinical Research Inc
Victoria
Mexico8 sites
Investigational Site
Acapulco
Hospital Christus Muguerza del Parque
Chihuahua, Chih.
Investigational Sit
Durango
Hospital Aranda de la Parra , S.A. de C.V.
Leon, GTO
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
Mexico City
Investigational Site
Mexico City
Consultorio Medico
Zapopan, Jalisco
Investigational Site
Zapopan, Jalisco
Czechia7 sites
Urocentrum Brno
Brno
UROHELP - Bozetechova
Brno
Nemocnice Jindrichuv Hradec, a.s.
Jindřichův Hradec
Fakultni Nemocnice Olomouc
Olomouc
Slezska nemocnice
Opava
Fakultni nemocnice v Motole, Prague5
Prague
Vseobecna fakultni nemocnice v Praze, Prague2
Prague
Hungary7 sites
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest
Dombóvári Szent Lukács Egészségügyi Kht.
Dombóvár
Petz Aladár Megyei Oktató Kórház
Győr
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
Investigational Site
Szeged
Romania7 sites
Investigational Site
Arad
Fundeni Uronephrology and Renal Transplant Clinical Institute
Bucharest
Investigational Site
Bucharest
Sfantul Ioan" Emergency Clinical Hospital
Bucharest
PROVITA 2000 Medical Center
Constanța
Investigational Site
Iași
Sibiu Emergency Clinical County Hospital
Sibiu
Russia6 sites
City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow
City Clinical Hospital #60
Moscow
Moscow State University of Medicine and Dentistry
Moscow
City Pokrovskaya Hospital
Saint Petersburg
Investigational Site
Saint Petersburg
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
Saint Petersburg
Ukraine4 sites
Dnipropetrovsk State Medical Academy
Dnipropetrovsk
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
Kharkiv
Kyiv City Clinical Hospital #3
Kyiv
Odesa State Medical University
Odesa
Netherlands3 sites
Investigational Site
Ede
Investigational Site
Eindhoven
Atrium MC
Heerlen
Germany2 sites
Klinikum Mannheim Universitätsklinikum GmbH
Mannheim
Klinikum der Universität Regensburg
Regensburg
United Kingdom1 site
Clatterbridge Centre For Oncology
Bebington, Wirral
About this study
Official title: An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix 80 mg / Degarelix 80 mg, Degarelix 160 mg / Degarelix 160 mg, Leuprolide 7.5 mg / Degarelix 80 mg, Leuprolide 7.5 mg / Degarelix 160 mg
- Keywords
- Degarelix, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix 80 mg / Degarelix 80 mgDrug
Also called Firmagon
Degarelix 160 mg / Degarelix 160 mgDrug
Also called Firmagon
Leuprolide 7.5 mg / Degarelix 80 mgDrug
Also called Firmagon, Lupron
Leuprolide 7.5 mg / Degarelix 160 mgDrug
Also called Firmagon, Lupron
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 80 mg / Degarelix 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 subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. Receives: Drug: Degarelix 80 mg / Degarelix 80 mg |
| Degarelix 160 mg / Degarelix 160 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 subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. Receives: Drug: Degarelix 160 mg / Degarelix 160 mg |
| Leuprolide 7.5 mg / Degarelix 80 mg | Experimental | During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. Receives: Drug: Leuprolide 7.5 mg / Degarelix 80 mg |
| Leuprolide 7.5 mg / Degarelix 160 mg | Experimental | During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.
Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.
Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. Receives: Drug: Leuprolide 7.5 mg / Degarelix 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Measured: Up to 4 years of treatment
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
Measured: Up to 4 years of treatment
Secondary outcomes (6)
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
Measured: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.
In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study.
Measured: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Measured: From time of switch to Day 56
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Measured: From time of switch to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Measured: From time of switch to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Measured: From time of switch to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2011
- Study completionDec 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
- 386 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
- NCT00451958
- Sponsor's protocol ID
- FE200486 CS21A
- Other IDs
- 2006-006913-34
- Status last verified
- Mar 2013
- First submitted
- 23 Mar 2007
- Last updated
- 21 Mar 2013
- 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 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
- ClinicalTrials.gov ID
- NCT00451958
- Acronym / sponsor ID
- FE200486 CS21A
- Conditions
- Prostate Cancer
- Keywords
- Degarelix, prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Mar 2007 (estimated)
- Results
- Posted 21 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Degarelix 80 mg / Degarelix 80 mg | Experimental | Drug: Degarelix 80 mg / Degarelix 80 mgThe 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 subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. |
| Degarelix 160 mg / Degarelix 160 mg | Experimental | Drug: Degarelix 160 mg / Degarelix 160 mgThe 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 subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. |
| Leuprolide 7.5 mg / Degarelix 80 mg | Experimental | Drug: Leuprolide 7.5 mg / Degarelix 80 mgDuring the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. |
| Leuprolide 7.5 mg / Degarelix 160 mg | Experimental | Drug: Leuprolide 7.5 mg / Degarelix 160 mgDuring the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Signed informed consent
- The patients must have completed the FE 200486 CS21 Study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Degarelix 80 mg / Degarelix 80 mgAlso: Firmagon | Drug | Degarelix 80 mg / Degarelix 80 mg |
| Degarelix 160 mg / Degarelix 160 mgAlso: Firmagon | Drug | Degarelix 160 mg / Degarelix 160 mg |
| Leuprolide 7.5 mg / Degarelix 80 mgAlso: Firmagon, Lupron | Drug | Leuprolide 7.5 mg / Degarelix 80 mg |
| Leuprolide 7.5 mg / Degarelix 160 mgAlso: Firmagon, Lupron | Drug | Leuprolide 7.5 mg / Degarelix 160 mg |
Primary outcome
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: Up to 4 years 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 (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: Up to 4 years of treatment
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
6 secondary outcomes
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
Time frame: Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Time frame: From time of switch to Day 56
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time frame: From time of switch to Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- 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
69 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix 80 mg / Degarelix 80 mg, Degarelix 160 mg / Degarelix 160 mg and Leuprolide 7.5 mg / Degarelix 80 mg in people with Prostate Cancer, run by Ferring Pharmaceuticals at 69 sites in 12 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 3 inclusion and 0 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 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Canada, Mexico, Czechia, Hungary and 7 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 21 Mar 2013). 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?
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight (time frame: Up to 4 years of treatment). 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 NCT00451958, 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 21 Mar 2013.