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

Phase 2

Completed

Brief Summary: 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.

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

Recruitment & Eligibility

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:

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Degarelix 240/240@60(1-3-6-9)	Degarelix	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).
Degarelix 240/240@40(1-3-6-9)	Degarelix	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).
Degarelix 240/240@60(1-4-7-10)	Degarelix	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	Baseline and up to 4.5 years	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	4.5 years	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.

Secondary Outcome Measures

Name	Time	Method

Locations (23): UZ Gasthuisberg Leuven
🇧🇪
Leuven, Belgium
Helsinki University Hospital, Maria Hospital, Building 11
🇫🇮
Helsinki, Finland
Central Hospital, North Karelian
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Joensuu, Finland
Oulu University Hospital
🇫🇮
Oulu, Finland
Tampere University Hospital
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Tampere, Finland
Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
🇫🇷
Nice, France
Gemeinschaftspraxis Dres Effert und Benedic
🇩🇪
Aachen, Germany
Clinical Center Novi Sad, Clinic of Urology
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Novi Sad, Montenegro
Academic Medical Center, Urology
🇳🇱
Amsterdam, Netherlands
St. Elisabeth Hospital
🇳🇱
Tilburg, Netherlands
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UZ Gasthuisberg Leuven
🇧🇪Leuven, Belgium