Prostate CancerNCT05181800
FIRMAGON® Intensive Drug Monitoring
An observational study of Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in China.
Trial summary
To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON®). 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 Cohort
- How many people
- 1,454 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Adult participants with diagnosis of prostate cancer needing ADT.
Who may be able to join
- Diagnosed with prostate cancer and in need of ADT
- Decision made to prescribe FIRMAGON® prior to enrollment
- Willingness and ability to provide written informed consent
- The participants are taking the marketed drug FIRMAGON®
Who cannot join
- Not signed informed consent
- Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer in Need of Androgen Deprivation Therapy
To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON®).
Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix Cohort
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix CohortOther
Also called FIRMAGON®
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| FIRMAGON® Cohort | Not described Receives: Other: Degarelix Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Any Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.
Measured: From the signing of the informed consent up to the end-of-trial (12 months)
Percentage of Participants With Serious AEs
An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction.
Measured: From the signing of the informed consent up to the end-of-trial (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start20 Aug 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,454 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
- NCT05181800
- Sponsor's protocol ID
- 000351
- Status last verified
- Sep 2024
- First submitted
- 20 Dec 2021
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer in Need of Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT05181800
- Acronym / sponsor ID
- 000351
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,454 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON®).
Study Design
This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIRMAGON® Cohort | – | Other: Degarelix Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with diagnosis of prostate cancer needing ADT.
Key inclusion criteria (4 listed)
- Diagnosed with prostate cancer and in need of ADT
- Decision made to prescribe FIRMAGON® prior to enrollment
- Willingness and ability to provide written informed consent
- The participants are taking the marketed drug FIRMAGON®
Key exclusion criteria (2 listed)
- Not signed informed consent
- Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this 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 |
|---|---|---|
| Degarelix CohortAlso: FIRMAGON®Non-interventional | Other | FIRMAGON® Cohort |
Primary outcome
Percentage of Participants With Any Adverse Events (AEs)
Time frame: From the signing of the informed consent up to the end-of-trial (12 months)
An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.
Percentage of Participants With Serious AEs
Time frame: From the signing of the informed consent up to the end-of-trial (12 months)
An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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.
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 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 4 inclusion and 2 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 Sep 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2024). 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?
Percentage of Participants With Any Adverse Events (AEs) (time frame: From the signing of the informed consent up to the end-of-trial (12 months)). The study lists 2 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 27 Sep 2024.