A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
degarelix
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tampereen yliopistollinen sairaala (there may be other sites in this country)
- Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
- Universitaetsklinikum Freiburg (there may be other sites in this country)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Injection A
Injection B
Injection C
Arm Description
Degarelix s.c. standard injections
Degarelix s.c. optimised injections
Degarelix i.m. injections
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02526784
Brief Title
A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
Official Title
A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection A
Arm Type
Active Comparator
Arm Description
Degarelix s.c. standard injections
Arm Title
Injection B
Arm Type
Experimental
Arm Description
Degarelix s.c. optimised injections
Arm Title
Injection C
Arm Type
Experimental
Arm Description
Degarelix i.m. injections
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
Firmagon
Primary Outcome Measure Information:
Title
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
Description
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time Frame
From baseline to month 6
Secondary Outcome Measure Information:
Title
Patient reported injection site pain scores after degarelix starting dose
Description
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time Frame
From starting dose to 6 days after starting dose
Title
Patient reported injection site pain scores after degarelix maintenance doses
Description
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
Time Frame
From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)
Title
Difference in skin colour values between pre- and post-injection
Description
Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter
Time Frame
From baseline to month 6
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Tampereen yliopistollinen sairaala (there may be other sites in this country)
City
Tampere
Country
Finland
Facility Name
Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
City
Bordeaux
Country
France
Facility Name
Universitaetsklinikum Freiburg (there may be other sites in this country)
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
We'll reach out to this number within 24 hrs