Prostate Cancer
Conditions
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.
Interventions
DRUGdegarelix
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From baseline to month 6 | Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported injection site pain scores after degarelix starting dose | From starting dose to 6 days after 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 | From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6) | 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 | From baseline to month 6 | Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter |
Countries
Finland, France, Germany
Outcome results
None listed