Prostate CancerPhase 2NCT00819247
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 16 sites in United Kingdom.
Trial summary
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. 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
- 129 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- Mar 2001to Aug 2002
- Phase
- Phase 2
- 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
- Signed informed consent before any trial related activity
- Proven prostate cancer with a need for endocrine treatment
- Testosterone level within the normal range for the age
Who cannot join
- Previous or current hormonal treatment of prostate cancer
- Candidate for prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions or Quincke's Oedema
- Hypersensitivity towards any component of FE200486
- Cancer disease within the last ten years except for prostate cancer and some skin cancers
- Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
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- Mental incapacity or language barrier
- Having received an investigational product within the last 12 weeks preceding the trial
- Previous participation in this trial
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites
Ayr Hospital
Ayr
Bristol Royal Infirmary
Bristol
Southmead Hospital
Bristol
St. Richards Hospital
Chichester
Glan Clwyd Hospital
Denbighshire
Ninewells Hospital
Dundee
Southern General Hospital
Glasgow
Leicester General Hospital
Leicester
Chelsea and Westminster Hospital
London
Kings College Hospital
London
St. Bartholemews Hospital
London
Derriford Hospital
Plymouth
Lister Hospital
Stevenage
Stirling Royal Infirmary
Stirling
Morriston Hospital
Swansea
Pindersfields General Hospital
Wakefield
About this study
Official title: A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
Read the detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix
- 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 FE 200486
Given as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 80/80 + 40 | Experimental | Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. Receives: Drug: Degarelix |
| Degarelix 40/40 + 40 | Experimental | Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. Receives: Drug: Degarelix |
| Degarelix 80 + 20 | Experimental | Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Measured: Weeks 1,2,4,8,12,16,20,24
Secondary outcomes (6)
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Measured: Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.
Measured: Weeks 4-24
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.
Measured: Six months
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).
Measured: Weeks 12, 24
The Number of Participants With Abnormal Liver Function Tests
The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.
Measured: Six months
Percentage Change in Vital Signs and Body Weight
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
Measured: Baseline and Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startMar 2001
- Primary completionMay 2002
- Study completionAug 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819247
- Sponsor's protocol ID
- FE200486 CS02
- Status last verified
- May 2011
- First submitted
- 7 Jan 2009
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00819247
- Acronym / sponsor ID
- FE200486 CS02
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- May 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 31 Mar 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
Detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degarelix 80/80 + 40 | Experimental | Drug: DegarelixLoading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. |
| Degarelix 40/40 + 40 | Experimental | Drug: DegarelixLoading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. |
| Degarelix 80 + 20 | Experimental | Drug: DegarelixLoading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140. |
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)
- Signed informed consent before any trial related activity
- Proven prostate cancer with a need for endocrine treatment
- Testosterone level within the normal range for the age
Key exclusion criteria (9 listed)
- Previous or current hormonal treatment of prostate cancer
- Candidate for prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions or Quincke's Oedema
- Hypersensitivity towards any component of FE200486
- Cancer disease within the last ten years except for prostate cancer and some skin cancers
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: FE 200486Given as a subcutaneous injection. | Drug | Degarelix 40/40 + 40, Degarelix 80 + 20, Degarelix 80/80 + 40 |
Primary outcome
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Time frame: Weeks 1,2,4,8,12,16,20,24
6 secondary outcomes
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Time frame: Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Time frame: Weeks 4-24
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Time frame: Six months
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Time frame: Weeks 12, 24
The Number of Participants With Abnormal Liver Function Tests
Time frame: Six months
Percentage Change in Vital Signs and Body Weight
Time frame: Baseline and Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- 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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 16 sites in United Kingdom.
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 9 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 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 31 Mar 2009). 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 Testosterone <0.5 Nanogram/Milliliter (time frame: Weeks 1,2,4,8,12,16,20,24). 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 9 Nov 2023.