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

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: Degarelix 160 mg / Degarelix 160 mg
Drug: Leuprolide 7.5 mg / Degarelix 160 mg
Drug: Degarelix 80 mg / Degarelix 80 mg
Drug: Leuprolide 7.5 mg / Degarelix 80 mg

Registration Number: NCT00451958

Lead Sponsor: Ferring Pharmaceuticals

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 386

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 160 mg / Degarelix 160 mg	Degarelix 160 mg / Degarelix 160 mg	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.
Leuprolide 7.5 mg / Degarelix 160 mg	Leuprolide 7.5 mg / Degarelix 160 mg	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.
Degarelix 80 mg / Degarelix 80 mg	Degarelix 80 mg / Degarelix 80 mg	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.
Leuprolide 7.5 mg / Degarelix 80 mg	Leuprolide 7.5 mg / Degarelix 80 mg	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	Up to 4 years of treatment	This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables	Up to 4 years of treatment	This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression	Until all participants have received at least 5 years of treatment and at a frequency of every 3 months	PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards	Until all participants have received at least 5 years of treatment and at a frequency of every 6 months	The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56	From time of switch to Day 56
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56	From time of switch to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56	From time of switch to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56	From time of switch to Day 56

Trial Locations

Locations (54): South Orange County Medical Research Center
🇺🇸
Laguna Hills, California, United States
Seattle Urology Research Center
🇺🇸
Burien, Washington, United States
Urology Associates Research
🇺🇸
Englewood, Colorado, United States
Hospital Christus Muguerza del Parque
🇲🇽
Chihuahua, Chih., Mexico
Odesa State Medical University
🇺🇦
Odesa, Ukraine
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
🇭🇺
Miskolc, Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
🇭🇺
Miskolc, Hungary
Atrium MC
🇳🇱
Heerlen, Netherlands
Dnipropetrovsk State Medical Academy
🇺🇦
Dnipropetrovsk, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
🇺🇦
Kharkiv, Ukraine
Hospital Aranda de la Parra , S.A. de C.V.
🇲🇽
Leon, GTO, Mexico
Pécsi Tudományegyetem
🇭🇺
Pécs, Hungary
Burlington Professional Centre
🇨🇦
Burlington, Ontario, Canada
Sibiu Emergency Clinical County Hospital
🇷🇴
Sibiu, Romania
City Clinical Hospital #60
🇷🇺
Moscow, Russian Federation
Urology Centers Of Alabama
🇺🇸
Homewood, Alabama, United States
Western Clinical Research
🇺🇸
Torrance, California, United States
South Florida Medical Research
🇺🇸
Aventura, Florida, United States
Investigational Site
🇷🇺
St. Petersburg, Russian Federation
Lawrenceville Urology
🇺🇸
Lawrenceville, New Jersey, United States
North Urology Research
🇺🇸
Concord, North Carolina, United States
State College Urologic Association
🇺🇸
State College, Pennsylvania, United States
The Female/Male Health Centres
🇨🇦
Oakville, Ontario, Canada
The Urology Research Centre
🇨🇦
Burlington, Ontario, Canada
Can-Med Clinical Research Inc
🇨🇦
Victoria, Canada
Urocentrum Brno
🇨🇿
Brno, Czech Republic
Nemocnice Jindrichuv Hradec, a.s.
🇨🇿
Jindrichuv Hradec, Czech Republic
UROHELP - Bozetechova
🇨🇿
Brno, Czech Republic
Fakultni Nemocnice Olomouc
🇨🇿
Olomouc, Czech Republic
Slezska nemocnice
🇨🇿
Opava, Czech Republic
Vseobecna fakultni nemocnice v Praze, Prague2
🇨🇿
Prague, Czech Republic
Klinikum der Universität Regensburg
🇩🇪
Regensburg, Germany
Klinikum Mannheim Universitätsklinikum GmbH
🇩🇪
Mannheim, Germany
Fövárosi Önkormányzat uzsoki utcai Kórház
🇭🇺
Budapest, Hungary
Petz Aladár Megyei Oktató Kórház
🇭🇺
Györ, Hungary
Dombóvári Szent Lukács Egészségügyi Kht.
🇭🇺
Dombóvár, Hungary
Clatterbridge Centre For Oncology
🇬🇧
Bebington, Wirral, United Kingdom
City Pokrovskaya Hospital
🇷🇺
St. Petersburg, Russian Federation
Fundeni Uronephrology and Renal Transplant Clinical Institute
🇷🇴
Bucharest, Romania
PROVITA 2000 Medical Center
🇷🇴
Constanta, Romania
Brantford Urology Research
🇨🇦
Brantford, Ontario, Canada
City Clinical Hospital #1 n.a. N.I.Pirogov
🇷🇺
Moscow, Russian Federation
Moscow State University of Medicine and Dentistry
🇷🇺
Moscow, Russian Federation
Fakultni nemocnice v Motole, Prague5
🇨🇿
Prague, Czech Republic
Investigational Sit
🇲🇽
Durango, Mexico
Sfantul Ioan" Emergency Clinical Hospital
🇷🇴
Bucharest, Romania
Urology South Shore Research
🇨🇦
Greenfields, Quebec, Canada
Hospital Andres Grillasca
🇵🇷
Ponce, Puerto Rico
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
🇷🇺
St. Petersburg, Russian Federation
Regional Urology
🇺🇸
Shreveport, Louisiana, United States
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
🇲🇽
Mexico, DF, Mexico
Consultorio Medico
🇲🇽
Zapopan, Jalisco, Mexico
Kyiv City Clinical Hospital #3
🇺🇦
Kyiv, Ukraine
Urology San Antonio Research
🇺🇸
San Antonio, Texas, United States