Advanced Hormone Sensitive Prostate CancerNCT02229253
Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer
An observational study of Advanced Hormone Sensitive Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in Netherlands.
Trial summary
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Advanced Hormone Sensitive Prostate Cancer
- What is being tested?
- degarelix
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to 4 Oct 2017
- 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 will be selected from prostate cancer patients in a hospital setting, meeting the inclusion criteria.
Who may be able to join
- Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer
Who cannot join
- Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
- Planned intermittent or short-term (< 12 months) degarelix treatment
- Planned addition of, or switch to another form of androgen deprivation therapy during the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Groene Hart Ziekenhuis (there may be other sites in this country)
Gouda
About this study
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.
- Being tested
- degarelix
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 |
|---|---|---|
| Degarelix | 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.
Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion4 Oct 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hormone Sensitive 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 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
- NCT02229253
- Sponsor's protocol ID
- 000171
- Status last verified
- Nov 2017
- First submitted
- 28 Aug 2014
- Last updated
- 27 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Data of Cardiovascular Events Occuring During Degarelix Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02229253
- Acronym / sponsor ID
- 000171
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 1 Sep 2014 (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.
Patients with prostate cancer and a history of cardiovascular disease treated with degarelix for their prostate cancer, will be followed for a period of one year. In this real-life, non-interventional trial, any cardiovascular events occurring during degarelix therapy will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degarelix | – | 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 will be selected from prostate cancer patients in a hospital setting, meeting the inclusion criteria.
Key inclusion criteria (1 listed)
- Patients with prostate cancer and a history of cardiovascular disease, prescribed degarelix for the treatment of their prostate cancer
Key exclusion criteria (3 listed)
- Patients who have received a form of androgen deprivation therapy for their prostate cancer, during the 12 months preceding this study are excluded
- Planned intermittent or short-term (< 12 months) degarelix treatment
- Planned addition of, or switch to another form of androgen deprivation therapy during the study
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 | Degarelix |
Primary outcome
Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice
Time frame: Up to 1 year
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 27 Nov 2017.
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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?
An observational study of Advanced Hormone Sensitive Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in Netherlands.
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 3 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 27 Nov 2017. 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 Netherlands. 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?
Cardiovascular event rate in hormone naïve prostate cancer patients with cardiovascular comorbidity at baseline, treated with degarelix in daily practice (time frame: Up to 1 year). 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 27 Nov 2017.