Prostate CancerNCT02886598
Safety and Efficacy of Firmagon® (Degarelix) for Injection
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- degarelix
- How many people
- 368 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to 26 Mar 2019
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who visit department of Urology in hospitals for treatment of prostate cancer.
Who may be able to join
- Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.
Who cannot join
- Patients with previous or concurrent known hypersensitivity to any component of the drug.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Severance Hospital (there may be other sites in this country)
Seoul
About this study
Official title: Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection
The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.
- 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 Firmagon®
| Study group | Role | What they receive |
|---|---|---|
| Firmagon® | Treatment according to standard clinical practice. Receives: Drug: degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886598
- Sponsor's protocol ID
- 000260
- Status last verified
- Jun 2019
- First submitted
- 29 Aug 2016
- Last updated
- 17 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection
- ClinicalTrials.gov ID
- NCT02886598
- Acronym / sponsor ID
- 000260
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 1 Sep 2016 (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.
The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firmagon® | – | Drug: degarelixTreatment according to standard clinical practice. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visit department of Urology in hospitals for treatment of prostate cancer.
Key inclusion criteria (1 listed)
- Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.
Key exclusion criteria (1 listed)
- Patients with previous or concurrent known hypersensitivity to any component of the drug.
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: Firmagon® | Drug | Firmagon® |
Primary outcome
Incidence of adverse events
Time frame: Up to 12 months
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 17 Jun 2019.
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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.
Global Clinical Compliance 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?
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in South Korea.
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 17 Jun 2019. 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 South Korea. 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.
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?
Incidence of adverse events (time frame: Up to 12 months). 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 17 Jun 2019.