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

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02526784

2015-000357-20 (EudraCT Number)

000184

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Injection A

Active Comparator group

Description:

Degarelix s.c. standard injections

Treatment:

Drug: degarelix

Injection B

Experimental group

Description:

Degarelix s.c. optimised injections

Treatment:

Drug: degarelix

Injection C

Experimental group

Description:

Degarelix i.m. injections

Treatment:

Drug: degarelix