Prostate CancerPhase 3PandaExtensionNCT02015871
An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer
A Phase 3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in China.
Trial summary
This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to 1 Aug 2017
- 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
- Has given written informed consent before 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 000006 trial
Who cannot join
- Has been withdrawn/discontinued from the 000006 trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital (there may be multiple sites in this country)
Beijing, Beijing Municipality
About this study
Official title: An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | Not described Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with Adverse Events (AEs)
Measured: Baseline to Month 26
Change in ECG parameters
Measured: Baseline to Month 26
Change in body weight and vital signs
Measured: Baseline to Month 26
Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)
Measured: Baseline to Month 26
Secondary outcomes (3)
Change in testosterone levels
Measured: Baseline to Month 26
Change in prostate-specific antigen (PSA) levels
Measured: Baseline to Month 26
Cumulative probability of no PSA failure
PSA failure is defined as two consecutive (at least two weeks apart) increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either trial 000006 or trial 000006A)
Measured: Baseline to Month 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 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
- NCT02015871
- Sponsor's protocol ID
- 000006A
- Acronym
- PandaExtension
- Status last verified
- Aug 2017
- First submitted
- 13 Dec 2013
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
- ClinicalTrials.gov ID
- NCT02015871
- Acronym / sponsor ID
- PandaExtension / 000006A
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 19 Dec 2013 (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.
This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.
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: Degarelix |
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 informed consent before 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 000006 trial
Key exclusion criteria (1 listed)
- Has been withdrawn/discontinued from the 000006 trial.
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 and percentage of patients with Adverse Events (AEs)
Time frame: Baseline to Month 26
Change in ECG parameters
Time frame: Baseline to Month 26
Change in body weight and vital signs
Time frame: Baseline to Month 26
Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)
Time frame: Baseline to Month 26
3 secondary outcomes
Change in testosterone levels
Time frame: Baseline to Month 26
Change in prostate-specific antigen (PSA) levels
Time frame: Baseline to Month 26
Cumulative probability of no PSA failure
Time frame: Baseline to Month 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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
1 site in 1 country: 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 1 site in China.
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 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and percentage of patients with Adverse Events (AEs) (time frame: Baseline to Month 26). The study lists 4 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 18 Jun 2023.