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

NCT ID: NCT02526784

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injection A

Degarelix s.c. standard injections

Group Type: ACTIVE_COMPARATOR

degarelix

Intervention Type: DRUG

Injection B

Degarelix s.c. optimised injections

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Injection C

Degarelix i.m. injections

Group Type: EXPERIMENTAL

degarelix

Intervention Type: DRUG

Interventions

degarelix

Intervention Type: DRUG

Other Intervention Names

Firmagon

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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 im Breisgau, , Germany

Countries

Finland; France; Germany

Other Identifiers

2015-000357-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000184

Identifier Type: -

Identifier Source: org_study_id