Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

• Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline and up to 4.5 years ] [ Designated as safety issue: No ]
  This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
• Liver Function Tests [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
  The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

• • Changes in clinical safety parameters (adverse events including death from any cause, local tolerability, physical examination, vital signs, ECG and body weight)
• • Clinically significant changes in laboratory safety parameters (biochemistry and haematology)

• • Time to testosterone serum level above 0.5 ng/mL
• • Time to disease progression (death from any cause, introduction of additional therapy-related to the prostate cancer or PSA progression)
• • Testosterone and PSA response over the entire treatment period.

The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

• Experimental: Degarelix 240/240@40(1-3-6-9)
  Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
  Intervention: Drug: Degarelix
• Experimental: Degarelix 240/240@60(1-3-6-9)
  Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
  Intervention: Drug: Degarelix
• Experimental: Degarelix 240/240@60(1-4-7-10)
  Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
  Intervention: Drug: Degarelix

Inclusion Criteria:

• Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has successfully completed the main study.

Exclusion Criterion:

- Has been withdrawn from the main study.