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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526784
• Other study ID #: 000184
• Secondary ID: 2015-000357-20
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2015
• Last updated: July 3, 2017
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• degarelix

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Finland,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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