Prostate CancerPhase 3NCT00728533
Open-Label, Randomised Parallel-Group Study
A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals.
Trial summary
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
- Screening PSA level of =2 ng/mL. ECOG score of =2.
- Life expectancy of at least one year.
- CRITERIA FOR EVALUATION:
- Primary endpoint:
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- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.
- Secondary endpoints:
- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
- Serum levels of testosterone, LH, FSH, and PSA over time.
- Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
- Plasma levels of degarelix over time.
- Frequency and severity of adverse events.
- Clinically significant changes in laboratory safety parameters.
- Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
Who cannot join
None listed.
About this study
Official title: The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix
- Keywords
- Prostate Cancer requiring Androgen Ablation Therapy
- 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
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
DegarelixDrug
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
* Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months Receives: Drug: Degarelix |
| 2 | Experimental | * Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
* Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
Measured: 3-month
Secondary outcomes (3)
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
Measured: 3-month
To evaluate pharmacokinetic response.
Measured: 3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
Why it stopped: Terminated due to awaiting data from Phase II study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT00728533
- Sponsor's protocol ID
- FE200486 CS26
- Other IDs
- 2007-006055-39
- Status last verified
- Mar 2011
- First submitted
- 18 Jan 2008
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
- ClinicalTrials.gov ID
- NCT00728533
- Acronym / sponsor ID
- FE200486 CS26
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer requiring Androgen Ablation Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to awaiting data from Phase II study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Degarelix* Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months |
| 2 | Experimental | Drug: Degarelix* Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
- Screening PSA level of =2 ng/mL. ECOG score of =2.
- Life expectancy of at least one year.
- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.
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 |
|---|---|---|
| DegarelixProstate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens. | Drug | 1 |
| DegarelixProstate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens. | Drug | 2 |
Primary outcome
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
Time frame: 3-month
3 secondary outcomes
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
Time frame: 3-month
To evaluate pharmacokinetic response.
Time frame: 3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
Time frame: 3-month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2011.
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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
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.
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 15 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: withdrawn, as of the sponsor's last update on 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. (time frame: 3-month). 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 18 Mar 2011.