Prostate CancerPhase 3NCT02526784
A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
A Phase 3 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 3 sites in 3 countries.
Trial summary
The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2015to Jun 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
- Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated.
- Caucasian origin.
- Able to provide written Informed Consent and willing and able to comply with trial procedures.
- Body mass index (BMI) between 18.5-30 kg/m2.
- Has a life expectancy of at least one year.
Who cannot join
- Current hormonal management of prostate cancer.
- Previous endocrine therapy for prostate cancer within 3 months prior to the screening visit.
- Any medical injection therapy that might interfere with degarelix injections.
- Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix.
- Any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease).
- Chronic pain syndrome or any continuous pain reported by the patient that, according to the judgement of the Investigator, could limit the evaluation of injection related pain.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Finland1 site
Tampereen yliopistollinen sairaala (there may be other sites in this country)
Tampere
France1 site
Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
Bordeaux
Germany1 site
Universitaetsklinikum Freiburg (there may be other sites in this country)
Freiburg im Breisgau
About this study
Official title: A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.
- 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 |
|---|---|---|
| Injection A | Active comparator | Degarelix s.c. standard injections Receives: Drug: degarelix |
| Injection B | Experimental | Degarelix s.c. optimised injections Receives: Drug: degarelix |
| Injection C | Experimental | Degarelix i.m. injections Receives: Drug: degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Measured: From baseline to month 6
Secondary outcomes (3)
Patient reported injection site pain scores after degarelix starting dose
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Measured: From starting dose to 6 days after starting dose
Patient reported injection site pain scores after degarelix maintenance doses
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Measured: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)
Difference in skin colour values between pre- and post-injection
Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter
Measured: From baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2017
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT02526784
- Sponsor's protocol ID
- 000184
- Other IDs
- 2015-000357-20, 2015
- Status last verified
- Jul 2017
- First submitted
- 17 Aug 2015
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02526784
- Acronym / sponsor ID
- 000184
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Aug 2015 (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 trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection A | Active comparator | Drug: degarelixDegarelix s.c. standard injections |
| Injection B | Experimental | Drug: degarelixDegarelix s.c. optimised injections |
| Injection C | Experimental | Drug: degarelixDegarelix i.m. injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated.
- Caucasian origin.
- Able to provide written Informed Consent and willing and able to comply with trial procedures.
- Body mass index (BMI) between 18.5-30 kg/m2.
- Has a life expectancy of at least one year.
Key exclusion criteria (6 listed)
- Current hormonal management of prostate cancer.
- Previous endocrine therapy for prostate cancer within 3 months prior to the screening visit.
- Any medical injection therapy that might interfere with degarelix injections.
- Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix.
- Any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease).
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 | Injection A, Injection B, Injection C |
Primary outcome
Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
Time frame: From baseline to month 6
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
3 secondary outcomes
Patient reported injection site pain scores after degarelix starting dose
Time frame: From starting dose to 6 days after starting dose
Patient reported injection site pain scores after degarelix maintenance doses
Time frame: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)
Difference in skin colour values between pre- and post-injection
Time frame: From baseline to month 6
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 5 Jul 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
3 sites in 3 countries: 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 3 sites in 3 countries.
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 5 inclusion and 6 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, France, Germany. 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?
Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections (time frame: From baseline to month 6). 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 5 Jul 2017; AzTrials last refreshed its copy on 2 Nov 2026.