A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: degarelix


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection A<br>Degarelix s.c. standard injections | Drug: degarelix<br> <br> * Other names: Firmagon;|
| Experimental: Injection B<br>Degarelix s.c. optimised injections | Drug: degarelix<br> <br> * Other names: Firmagon;|
| Experimental: Injection C<br>Degarelix i.m. injections | Drug: degarelix<br> <br> * Other names: Firmagon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | From baseline to month 6 |