Prostate CancerPhase 3NCT00967018
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 62 sites in 7 countries.
Trial summary
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 62 sitesin 7 countries
- Study dates
- Aug 2009to 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
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
Who cannot join
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Trial locations and contacts
62 sites in 7 countries.
62 sites in 7 countries
France19 sites
Hopital Jean Minjoz
Besançon
Institut Bergonié
Bordeaux
Centre Francois Baclesse
Caen
CHU Henri Mondor
Créteil
Centre Oscar Lambret
Lille
Centre Leon Berard
Lyon
Hopital de la Timone
Marseille
CRLC Val d' Aurelle - Oncology Radiotherapy
Montpellier
Hôpital Saint Louis - Radiotherapy Departement
Paris
Hôpital Tenon
Paris
Clinique Francheville
Périgueux
CHU La Milétrie - Oncology Radiotherapy
Poitiers
Clinique Saint Brieuc
Saint-Brieuc
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
Saint-Herblain
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez
Centre Paul Strauss
Strasbourg
Centre de radiologie Saint Louis
Toulon
Clinique du Parc
Toulouse
IGR
Villejuif
Spain16 sites
Hospital Universitario Principe de Asturias
Alcalá de Henares-Madrid
Fundacion Hospital Alcorcón
Alcorcón
Fundación Puigvert
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d´Hebron
Barcelona
Hospital de Basurto
Bilbao
Hospital Clinico Universitario S. Carlos
Madrid
Hospital Doce de Octubre
Madrid
Hospital universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Manacor
Manacor
Hospital Universitario Central de Asturias
Oviedo
Hospital Santiago de Compostela
Santiago de Compostela
Hospital Virgen Macarena
Seville
Fundación IVO
Valencia
Hospital Xeral de Vigo
Vigo
Italy11 sites
Azienda Ospedaliero Universitaria Ospedali riuniti
Ancona
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
Bologna
Clinica Urologica 1 Universita Firenze
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
Sweden6 sites
Investigational site
Gothenburg
SU/Sahlgrenska
Gothenburg
Helsingborgs Lasarett
Helsingborg
Universitetssjukhuset MAS
Malmö
Södertälje Sjukhus
Södertälje
Uppsala/Akademiska sjukhuset
Uppsala
Portugal4 sites
Hospital Fernando da Fonseca
Amadora
Hospitais Universidade Coimbra
Coimbra
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
Lisbon
Hospital S.João
Porto
Turkey (Türkiye)4 sites
Ankara University Faculty of Medicine - Sıhhıye
Ankara
Cerrahpasa Faculty of Medicine - Kocamustafapasa
Istanbul
Istanbul University Faculty of Medicine - ÇAPA
Istanbul
Marmara University Faculty of Medicine - Altunizade
Istanbul
About this study
Official title: A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix
- Keywords
- Safety parameters, ECG, blood and urine samples, general health state
- 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
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. Receives: Drug: Degarelix |
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 Safety Laboratory Variables
The figures present the number of participants who had markedly abnormal 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: Up to 22.5 months
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: Up to 22.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 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
- NCT00967018
- Sponsor's protocol ID
- FE200486 CS34
- Other IDs
- EudraCT No: 2008-006827-29
- Status last verified
- Jan 2013
- First submitted
- 18 Aug 2009
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00967018
- Acronym / sponsor ID
- FE200486 CS34
- Conditions
- Prostate Cancer
- Keywords
- Safety parameters, ECG, blood and urine samples, general health state
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 24 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: DegarelixThe degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
Key exclusion criteria (1 listed)
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
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 | Drug | Degarelix |
Primary outcome
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time frame: Up to 22.5 months
The figures present the number of participants who had markedly abnormal 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.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame: Up to 22.5 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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
62 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 62 sites in 7 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 1 inclusion and 1 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in France, Spain, Italy, Sweden, Portugal and 2 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 24 Dec 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?
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables (time frame: Up to 22.5 months). 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?
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 Jan 2013.