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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: degarelix

• Registration Number: NCT02526784
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Study Start: 2015-12
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• 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.

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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection B	degarelix	Degarelix s.c. optimised injections
Injection C	degarelix	Degarelix i.m. injections
Injection A	degarelix	Degarelix s.c. standard injections

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Tampereen yliopistollinen sairaala (there may be other sites in this country); 🇫🇮 Tampere, Finland

Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country); 🇫🇷 Bordeaux, France

Universitaetsklinikum Freiburg (there may be other sites in this country); 🇩🇪 Freiburg, Germany