Clinical trial NCT02526784: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: From baseline to month 6
Secondary outcomes:
measure: Patient reported injection site pain scores after degarelix starting dose
timeFrame: From starting dose to 6 days after starting dose
measure: Patient reported injection site pain scores after degarelix maintenance doses
timeFrame: From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)
measure: Difference in skin colour values between pre- and post-injection
timeFrame: From baseline to month 6
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala (there may be other sites in this country)
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: