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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00268892
• Lead Sponsor: Ferring Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-23
• Study Start: 2006-01
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2010-11-17
• Results First Submitted QC: 2010-11-17
• Status Verified: 2010-12
• Results First Posted: 2010-12-06
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 278

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• Has been withdrawn from the main study.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (23)

Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur; 🇫🇷 Nice, France

UZ Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

Gemeinschaftspraxis Dres Effert und Benedic; 🇩🇪 Aachen, Germany

Helsinki University Hospital, Maria Hospital, Building 11; 🇫🇮 Helsinki, Finland

"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"; 🇷🇴 Arad, Romania

St. Elisabeth Hospital; 🇳🇱 Tilburg, Netherlands

University CF Hospital No. 2; 🇷🇴 Bucharest, Romania

Clinical Center Novi Sad, Clinic of Urology; 🇲🇪 Novi Sad, Montenegro

Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department; 🇷🇴 Bucharest, Romania

City Hospital #15; 🇷🇺 St. Petersburg, Russian Federation

City Hospital #26; 🇷🇺 St. Petersburg, Russian Federation

Mount Vernon Cancer Centre, Marie Cuire Research Wing; 🇬🇧 Northwood, Middlesex, United Kingdom

Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans; 🇬🇧 Falkirk, United Kingdom

Level 7, Urology Research Unit, Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department; 🇷🇺 St. Petersburg, Russian Federation

Andros Clinic; 🇷🇺 St. Petersburg, Russian Federation

Clinical Center of Serbia, Institute of Urology and Nephrology; 🇷🇸 Belgrade, Serbia

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Academic Medical Center, Urology; 🇳🇱 Amsterdam, Netherlands

Central Hospital, North Karelian; 🇫🇮 Joensuu, Finland

Pavlov State Medical University, Urology Department; 🇷🇺 St. Petersburg, Russian Federation

Castle Hill Hospital; 🇬🇧 Hull, North Humberside, United Kingdom