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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: degarelix

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Tampereen yliopistollinen sairaala (there may be other sites in this country)
• France
  • Bordeaux, France
    • Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
• Germany
  • Freiburg, Germany
    • Universitaetsklinikum Freiburg (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Injection A; Degarelix s.c. standard injections	Drug: degarelix; Other Names: Firmagon
Experimental: Injection B; Degarelix s.c. optimised injections	Drug: degarelix; Other Names: Firmagon
Experimental: Injection C; Degarelix i.m. injections	Drug: degarelix; Other Names: Firmagon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 000184; 2015-000357-20 (EudraCT Number)