Prostate CancerPhase 4NCT02726009
A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
A Phase 4 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 19 sites in India.
Trial summary
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 18 to 79 years, 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
- 230 participants
- Where
- 19 sitesIndia
- Study dates
- May 2016to 15 May 2020
- Phase
- Phase 4
- 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 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has given written informed consent before any study-related activity is performed
- Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
- Age greater than or equal to 18 years and less than 80 years
- Advanced hormone-dependent prostate cancer without any other clinically significant disorder
- Easten Cooperative Oncology Group score ≤ 2
- PSA ≥ 2 ng/mL at screening
- Life expectancy of at least 12 months as per the investigator's judgement
Who cannot join
- Previous or concurrent hormonal management of prostate cancer
- Contraindication for prescription of Firmagon®
- Concurrent treatment with a 5-α-reductase inhibitor
- Considered as a candidate for curative therapy
- History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
- QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
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- Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
- Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
- Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
- Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
India19 sites
Bodyline Hospitals
Ahmedabad
HCG Multi Specialty Hospital
Ahmedabad
Shalby Hospital
Ahmedabad
HealthCare Global Enterprises Limited
Bangalore
KLE's Dr. Prabhakar Kore Hospital & MRC
Belagavi
S. P Medical College and AG of Hospitals
Bikaner, Rajasthan
Apollo Speciality Hospital
Chennai
Rajiv Gandhi Cancer Institute and Research Centre
Delhi
Muljibhai Patel Urological Hospital
Gujrāt
CHL Hospital
Indore
SMS Medical College & Attached Hospital's
Jaipur
Tata Medical Center
Kolkata
King's George Medical University
Lucknow
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Mumbai
Tata Memorial Hospital
Mumbai
Government Medical College and Super Specialty Hospital
Nagpur
Rml & Pgimer
New Delhi
Krishna Institute of Medical Sciences
Secunderabad, Telangana
Aman Hospital and Research Center
Vadodara
About this study
Official title: An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
- 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 |
|---|---|---|
| Degarelix | Experimental | Not described Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: Up to Day 364
Severity of adverse events
Measured: Up to Day 364
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
Measured: From baseline to Day 364
Clinically significant changes in vital signs
Measured: From baseline to Day 364
Secondary outcomes (4)
Cumulative probability of no Prostate Specific Antigen (PSA) failure
PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart
Measured: Up to Day 364
Cumulative probability of Progression Free Survival (PFS)
PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first
Measured: Up to Day 364
Change in International Prostate Symptom Score (IPSS)
Measured: From baseline to Day 364
Change in physician's satisfaction score
Measured: From baseline to Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion15 May 2020
- Study completion15 May 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 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
- NCT02726009
- Sponsor's protocol ID
- 000201
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2016
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer
- ClinicalTrials.gov ID
- NCT02726009
- Acronym / sponsor ID
- 000201
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 1 Apr 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 open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
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 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has given written informed consent before any study-related activity is performed
- Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
- Age greater than or equal to 18 years and less than 80 years
- Advanced hormone-dependent prostate cancer without any other clinically significant disorder
- Easten Cooperative Oncology Group score ≤ 2
Key exclusion criteria (10 listed)
- Previous or concurrent hormonal management of prostate cancer
- Contraindication for prescription of Firmagon®
- Concurrent treatment with a 5-α-reductase inhibitor
- Considered as a candidate for curative therapy
- History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
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
Frequency of adverse events
Time frame: Up to Day 364
Severity of adverse events
Time frame: Up to Day 364
Clinically significant changes in laboratory values (hematology and clinical biochemistry)
Time frame: From baseline to Day 364
Clinically significant changes in vital signs
Time frame: From baseline to Day 364
4 secondary outcomes
Cumulative probability of no Prostate Specific Antigen (PSA) failure
Time frame: Up to Day 364
Cumulative probability of Progression Free Survival (PFS)
Time frame: Up to Day 364
Change in International Prostate Symptom Score (IPSS)
Time frame: From baseline to Day 364
Change in physician's satisfaction score
Time frame: From baseline to Day 364
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 15 Dec 2021.
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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
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 19 sites in India.
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 7 inclusion and 10 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Frequency of adverse events (time frame: Up to Day 364). 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 15 Dec 2021.