Back to resultsA Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix 80 mg / Degarelix 80 mg
Degarelix 160 mg / Degarelix 160 mg
Leuprolide 7.5 mg / Degarelix 80 mg
Leuprolide 7.5 mg / Degarelix 160 mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Degarelix, prostate cancer
Eligibility 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.
Sites / Locations
- Urology Centers Of Alabama
- South Orange County Medical Research Center
- Western Clinical Research
- Urology Associates Research
- South Florida Medical Research
- Investigational Site
- Regional Urology
- Lawrenceville Urology
- Investigational Site
- North Urology Research
- Investigational Site
- State College Urologic Association
- Urology San Antonio Research
- Seattle Urology Research Center
- Investigational Site
- The Female/Male Health Centres
- Brantford Urology Research
- Burlington Professional Centre
- The Urology Research Centre
- Investigational Site
- The Female/Male Health Centres
- Urology South Shore Research
- Can-Med Clinical Research Inc
- Urocentrum Brno
- UROHELP - Bozetechova
- Nemocnice Jindrichuv Hradec, a.s.
- Fakultni Nemocnice Olomouc
- Slezska nemocnice
- Fakultni nemocnice v Motole, Prague5
- Vseobecna fakultni nemocnice v Praze, Prague2
- Klinikum Mannheim Universitätsklinikum GmbH
- Klinikum der Universität Regensburg
- Fövárosi Önkormányzat uzsoki utcai Kórház
- Dombóvári Szent Lukács Egészségügyi Kht.
- Petz Aladár Megyei Oktató Kórház
- Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
- Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
- Pécsi Tudományegyetem
- Investigational Site
- Investigational Site
- Hospital Christus Muguerza del Parque
- Investigational Sit
- Hospital Aranda de la Parra , S.A. de C.V.
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
- Investigational Site
- Consultorio Medico
- Investigational Site
- Investigational Site
- Investigational Site
- Atrium MC
- Hospital Andres Grillasca
- Investigational Site
- Fundeni Uronephrology and Renal Transplant Clinical Institute
- Investigational Site
- Sfantul Ioan" Emergency Clinical Hospital
- PROVITA 2000 Medical Center
- Investigational Site
- Sibiu Emergency Clinical County Hospital
- City Clinical Hospital #1 n.a. N.I.Pirogov
- City Clinical Hospital #60
- Moscow State University of Medicine and Dentistry
- City Pokrovskaya Hospital
- Investigational Site
- St.Petersburg State Medical Academy n. a. I.I.Mechnikov
- Dnipropetrovsk State Medical Academy
- Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
- Kyiv City Clinical Hospital #3
- Odesa State Medical University
- Clatterbridge Centre For Oncology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Degarelix 80 mg / Degarelix 80 mg
Degarelix 160 mg / Degarelix 160 mg
Leuprolide 7.5 mg / Degarelix 80 mg
Leuprolide 7.5 mg / Degarelix 160 mg
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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
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
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
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
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
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00451958
Brief Title
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
Official Title
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Degarelix, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix 80 mg / Degarelix 80 mg
Arm Type
Experimental
Arm 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.
Arm Title
Degarelix 160 mg / Degarelix 160 mg
Arm Type
Experimental
Arm 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.
Arm Title
Leuprolide 7.5 mg / Degarelix 80 mg
Arm Type
Experimental
Arm 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.
Arm Title
Leuprolide 7.5 mg / Degarelix 160 mg
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Degarelix 80 mg / Degarelix 80 mg
Other Intervention Name(s)
Firmagon
Intervention Type
Drug
Intervention Name(s)
Degarelix 160 mg / Degarelix 160 mg
Other Intervention Name(s)
Firmagon
Intervention Type
Drug
Intervention Name(s)
Leuprolide 7.5 mg / Degarelix 80 mg
Other Intervention Name(s)
Firmagon, Lupron
Intervention Type
Drug
Intervention Name(s)
Leuprolide 7.5 mg / Degarelix 160 mg
Other Intervention Name(s)
Firmagon, Lupron
Primary Outcome Measure Information:
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
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.
Time Frame
Up to 4 years of treatment
Title
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description
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.
Time Frame
Up to 4 years of treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
Description
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).
Time Frame
Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
Title
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
Description
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.
Time Frame
Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
Title
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Time Frame
From time of switch to Day 56
Title
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame
From time of switch to Day 56
Title
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame
From time of switch to Day 56
Title
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Time Frame
From time of switch to Day 56
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers Of Alabama
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
Western Clinical Research
City
Torrance
State/Province
California
Country
United States
Facility Name
Urology Associates Research
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Investigational Site
City
Carmel
State/Province
New York
Country
United States
Facility Name
North Urology Research
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
State College Urologic Association
City
State College
State/Province
Pennsylvania
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Seattle Urology Research Center
City
Burien
State/Province
Washington
Country
United States
Facility Name
Investigational Site
City
Kentville
State/Province
Nova Scotia
Country
Canada
Facility Name
The Female/Male Health Centres
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Brantford Urology Research
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
Burlington Professional Centre
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
The Urology Research Centre
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
The Female/Male Health Centres
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfields
State/Province
Quebec
Country
Canada
Facility Name
Can-Med Clinical Research Inc
City
Victoria
Country
Canada
Facility Name
Urocentrum Brno
City
Brno
Country
Czech Republic
Facility Name
UROHELP - Bozetechova
City
Brno
Country
Czech Republic
Facility Name
Nemocnice Jindrichuv Hradec, a.s.
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Slezska nemocnice
City
Opava
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole, Prague5
City
Prague
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze, Prague2
City
Prague
Country
Czech Republic
Facility Name
Klinikum Mannheim Universitätsklinikum GmbH
City
Mannheim
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
Country
Germany
Facility Name
Fövárosi Önkormányzat uzsoki utcai Kórház
City
Budapest
Country
Hungary
Facility Name
Dombóvári Szent Lukács Egészségügyi Kht.
City
Dombóvár
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Györ
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Facility Name
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
City
Miskolc
Country
Hungary
Facility Name
Pécsi Tudományegyetem
City
Pécs
Country
Hungary
Facility Name
Investigational Site
City
Szeged
Country
Hungary
Facility Name
Investigational Site
City
Acapulco
Country
Mexico
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua, Chih.
Country
Mexico
Facility Name
Investigational Sit
City
Durango
Country
Mexico
Facility Name
Hospital Aranda de la Parra , S.A. de C.V.
City
Leon, GTO
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico, DF Mexico
City
Mexico, DF
Country
Mexico
Facility Name
Investigational Site
City
Mexico, DF
Country
Mexico
Facility Name
Consultorio Medico
City
Zapopan, Jalisco
Country
Mexico
Facility Name
Investigational Site
City
Zapopan, Jalisco
Country
Mexico
Facility Name
Investigational Site
City
Ede
Country
Netherlands
Facility Name
Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
Atrium MC
City
Heerlen
Country
Netherlands
Facility Name
Hospital Andres Grillasca
City
Ponce
Country
Puerto Rico
Facility Name
Investigational Site
City
Arad
Country
Romania
Facility Name
Fundeni Uronephrology and Renal Transplant Clinical Institute
City
Bucharest
Country
Romania
Facility Name
Investigational Site
City
Bucharest
Country
Romania
Facility Name
Sfantul Ioan" Emergency Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
PROVITA 2000 Medical Center
City
Constanta
Country
Romania
Facility Name
Investigational Site
City
Iasi
Country
Romania
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
Country
Romania
Facility Name
City Clinical Hospital #1 n.a. N.I.Pirogov
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital #60
City
Moscow
Country
Russian Federation
Facility Name
Moscow State University of Medicine and Dentistry
City
Moscow
Country
Russian Federation
Facility Name
City Pokrovskaya Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
St.Petersburg State Medical Academy n. a. I.I.Mechnikov
City
St. Petersburg
Country
Russian Federation
Facility Name
Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
City
Kharkiv
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
Country
Ukraine
Facility Name
Odesa State Medical University
City
Odesa
Country
Ukraine
Facility Name
Clatterbridge Centre For Oncology
City
Bebington, Wirral
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34350976
Citation
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
Results Reference
derived
Learn more about this trial
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
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