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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

degarelix

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Tampereen yliopistollinen sairaala (there may be other sites in this country)
Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
Universitaetsklinikum Freiburg (there may be other sites in this country)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Injection A

Injection B

Injection C

Arm Description

Degarelix s.c. standard injections

Degarelix s.c. optimised injections

Degarelix i.m. injections

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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

Full Information

NCT ID

NCT02526784

First Posted

August 17, 2015

Last Updated

July 3, 2017

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02526784

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Injection A

Arm Type

Active Comparator

Arm Description

Degarelix s.c. standard injections

Arm Title

Injection B

Arm Type

Experimental

Arm Description

Degarelix s.c. optimised injections

Arm Title

Injection C

Arm Type

Experimental

Arm Description

Degarelix i.m. injections

Intervention Type

Drug

Intervention Name(s)

degarelix

Other Intervention Name(s)

Firmagon

Primary Outcome Measure Information:

Title

Description

Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

Time Frame

From baseline to month 6

Secondary Outcome Measure Information:

Title

Patient reported injection site pain scores after degarelix starting dose

Description

Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

Time Frame

From starting dose to 6 days after starting dose

Title

Patient reported injection site pain scores after degarelix maintenance doses

Description

Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)

Time Frame

From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6)

Title

Difference in skin colour values between pre- and post-injection

Description

Average of 4 measurements on skin redness at the injection site using DSM II ColorMeter

Time Frame

From baseline to month 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Tampereen yliopistollinen sairaala (there may be other sites in this country)

City

Tampere

Country

Finland

Facility Name

Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)

City

Bordeaux

Country

France

Facility Name

Universitaetsklinikum Freiburg (there may be other sites in this country)

City

Freiburg

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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