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

Phase 1

Active, not recruiting

• Conditions: FIRMAGON is indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.; MedDRA version: 18.0Level: PTClassification code 10071119Term: Hormone-dependent prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000357-20-FI
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-08
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 120

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare the severity of ISR related pain following degarelix s.c. administrations with two different injection techniques and i.m. administration in prostate cancer patients during the 7-month trial period.;Secondary Objective: •To compare the severity of ISR related pain following s.c. administrations of degarelix starting dose with two different injection techniques and i.m. administration.<br>•To compare the severity of ISR related pain following s.c. administrations of degarelix maintenance doses with two different injection techniques and i.m. administration.<br>;Primary end point(s): Difference in the average patient reported injection site pain score (0=no pain, 10=worst possible pain) between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections, over the duration of the trial.;Timepoint(s) of evaluation of this end point: Over the duration of the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Patient reported injection site pain scores (0=no pain, 10=worst possible pain) evaluated for degarelix s.c. injection techniques and degarelix i.m. injection, at 30 minutes after injection, at bedtime the day of injection, and daily for 6 days after degarelix starting dose.<br>•Patient reported injection site pain scores (0=no pain, 10=worst possible pain) evaluated for degarelix s.c. injection techniques and degarelix i.m. injection, at 30 minutes after injection, at bedtime the day of injection, and daily for 6 days after degarelix maintenance doses.<br>•Difference in skin colour values (average of 4 measurements on skin redness [a*-axis: redgreen; CIE L*a*b* system] at the injection site using DSM II ColorMeter) between pre- and post-injection for all injection techniques across trial visits.;Timepoint(s) of evaluation of this end point: At 30 minutes after injection, at bedtime the day of injection, and daily for 6 days after degarelix maintenance doses.