A Study of Degarelix in Patients With Prostate Cancer

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Degarelix; Drug: Leuprolide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928434

FE200486 CS37

Details and patient eligibility

About

The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Full description

This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.

The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.

During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

Enrollment: 409 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older.
• Raising PSA after prior treatment failure of localized prostate cancer.
• Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
• Has a screening testosterone within normal range (≥1.5 ng/mL).
• Has Eastern Cooperative Oncology Group score of ≤2.
• Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
• Life expectancy of at least 15 months.

Exclusion criteria

• Taken hormone therapy in the last 6 months prior to entering this study.
• Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Has hypersensitivity towards any component of the study drug.
• Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
• Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
• Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
• Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
• Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
• Has previously participated in any Degarelix trial.
• Is part of an ongoing trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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409 participants in 3 patient groups

DI (Degarelix Intermittent)

Experimental group

Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered. During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Treatment:

Drug: Degarelix

Drug: Degarelix

DC (Degarelix Continuous)

Experimental group

Description:

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Treatment:

Drug: Degarelix

Drug: Degarelix

LC (Leuprolide Continuous)

Active Comparator group

Description:

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Treatment:

Drug: Leuprolide