A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Ferring

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Leuprolide 7.5 mg / Degarelix 80 mg; Drug: Degarelix 160 mg / Degarelix 160 mg; Drug: Leuprolide 7.5 mg / Degarelix 160 mg; Drug: Degarelix 80 mg / Degarelix 80 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451958

2006-006913-34 (EudraCT Number)

FE200486 CS21A

Details and patient eligibility

About

Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Enrollment: 386 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/Exclusion Criteria:

• Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
• Signed informed consent
• The patients must have completed the FE 200486 CS21 Study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 4 patient groups

Degarelix 80 mg / Degarelix 80 mg

Experimental group

Description:

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.

Treatment:

Drug: Degarelix 80 mg / Degarelix 80 mg

Degarelix 160 mg / Degarelix 160 mg

Experimental group

Description:

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Treatment:

Drug: Degarelix 160 mg / Degarelix 160 mg

Leuprolide 7.5 mg / Degarelix 80 mg

Experimental group

Description:

During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Treatment:

Drug: Leuprolide 7.5 mg / Degarelix 80 mg

Leuprolide 7.5 mg / Degarelix 160 mg

Experimental group

Description:

During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.

Treatment:

Drug: Leuprolide 7.5 mg / Degarelix 160 mg