Back to resultsA Degarelix Trial in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix
Goserelin acetate
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
- Has completed the CS35 trial.
Exclusion Criteria:
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Sites / Locations
- University of Colorado School of Medicine
- The Urology Center of Colorado
- Urology Associates of Dover, PA
- South Florida Medical Research
- Urology Group of New Mexico, PC
- Carolina Urologic Research Center
- Urology San Antonio Research, Pa
- Seattle Urology Research Center
- AZ Groeninge - Campus Sint-Maarten
- Jonathan Giddens Medicine Professional Corporation
- Southern Interior Medical Research Inc.
- Mor Urology, Inc.
- Investigational site
- Investigational site
- Urocentrum Brno
- Nemocnice Jindrichuv Hradec, a.s.
- Kromerizska nemocnice a.s.
- Fakultni nemocnice v Motole, Praha 5
- Vseobecna fakultni nemocnice v Praze, Praha 2
- Krajska nemocnice T. Bati a.s.
- ODL Terveys Oy
- Pohjois-Karjalan keskussairaala
- Tampereen yliopistollinen sairaala
- Gemeinschaftspraxis Rudolph & Wörner
- Urologische Studienpraxis
- Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
- Fövárosi Önkormányzat uzsoki utcai Kórház
- Semmelweis Egyetem
- Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
- Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
- Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
- Pécsi Tudományegyetem
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
- Jávorszky Ödön Kórház
- Hospital Christus Muguerza del Parque
- Hospital Angeles Culiacan
- Consultorio de Especialidad en Urologia Privado
- Hospital Angeles Lindavista
- Médica Sur, S.A.B. de C.V.
- Consultorio Medico
- MC Haaglanden
- Catharina-ziekenhuis
- SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
- Centrum Medyczne Medur Sp. z o.o.
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
- Private Medical Center SRL
- Brasov Emergency Clinical County Hospital
- "Prof. Dr. Th. Burghele" Clinical Hospital
- "Sfantul Ioan" Emergency Clinical Hospital
- Dinu Uromedica
- Fundeni Clinical Institute of Uronephrology and Renal Transplantation
- PROVITA 2000 Medical Center
- "Dr. C.I. Parhon" Clinical Hospital
- Vita Care Flav Medical Center
- Sibiu Emergency Clinical County Hospital
- Dnipropetrovsk State Medical Academy
- Donetsk Regional Clinical Territorial Medical Association
- Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
- Kyiv City Clinical Hospital #3
- Odesa Regional Clinical Hospital
- Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
- Ipswich Hospital
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Degarelix 240 mg/480 mg
Goserelin acetate
Arm Description
Outcomes
Primary Outcome Measures
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
Secondary Outcome Measures
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Full Information
NCT ID
NCT01242748
First Posted
November 16, 2010
Last Updated
May 13, 2015
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01242748
Brief Title
A Degarelix Trial in Patients With Prostate Cancer
Official Title
An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (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
A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.
Detailed Description
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).
In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).
It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).
The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Degarelix 240 mg/480 mg
Arm Type
Experimental
Arm Title
Goserelin acetate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
Firmagon, FE200486
Intervention Description
The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Intervention Type
Drug
Intervention Name(s)
Goserelin acetate
Other Intervention Name(s)
Zoladex
Intervention Description
The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Primary Outcome Measure Information:
Title
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
Description
PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.
Time Frame
From baseline to 3 years
Secondary Outcome Measure Information:
Title
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
Description
PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.
Time Frame
From baseline to 3 years
Title
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
Description
PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.
Time Frame
From baseline to 3 years
Title
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
Description
Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.
Time Frame
From baseline to 3 years
Title
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
Description
Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.
Time Frame
From baseline to 3 years
Title
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
Description
The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.
Time Frame
From baseline to 3 years
Title
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
Description
Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Time Frame
Baseline and after 1, 6, 12, 19, and 22 months
Title
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
Description
Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Time Frame
Baseline and after 1, 6, 12, 19, and 22 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
Has completed the CS35 trial.
Exclusion Criteria:
Has been withdrawn from the CS35 trial.
Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
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
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Urology Associates of Dover, PA
City
Dover
State/Province
Delaware
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Urology Group of New Mexico, PC
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Urology San Antonio Research, Pa
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
AZ Groeninge - Campus Sint-Maarten
City
Kortrijk
Country
Belgium
Facility Name
Jonathan Giddens Medicine Professional Corporation
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Southern Interior Medical Research Inc.
City
Kelowna
Country
Canada
Facility Name
Mor Urology, Inc.
City
Newmarket
Country
Canada
Facility Name
Investigational site
City
Scarborough
Country
Canada
Facility Name
Investigational site
City
Toronto
Country
Canada
Facility Name
Urocentrum Brno
City
Brno
Country
Czech Republic
Facility Name
Nemocnice Jindrichuv Hradec, a.s.
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Kromerizska nemocnice a.s.
City
Kromeriz
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole, Praha 5
City
Praha
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze, Praha 2
City
Praha
Country
Czech Republic
Facility Name
Krajska nemocnice T. Bati a.s.
City
Zlin
Country
Czech Republic
Facility Name
ODL Terveys Oy
City
Oulu
Country
Finland
Facility Name
Pohjois-Karjalan keskussairaala
City
Tampere
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
Country
Finland
Facility Name
Gemeinschaftspraxis Rudolph & Wörner
City
Kirchheim
Country
Germany
Facility Name
Urologische Studienpraxis
City
Nürtingen
Country
Germany
Facility Name
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
City
Budapest
Country
Hungary
Facility Name
Fövárosi Önkormányzat uzsoki utcai Kórház
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
City
Dombóvár
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
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
Country
Hungary
Facility Name
Jávorszky Ödön Kórház
City
Vác
Country
Hungary
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua, Chih.
Country
Mexico
Facility Name
Hospital Angeles Culiacan
City
Culiacan, Sinaloa
Country
Mexico
Facility Name
Consultorio de Especialidad en Urologia Privado
City
Durango
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Mexico City, DF
Country
Mexico
Facility Name
Médica Sur, S.A.B. de C.V.
City
Mexico City
Country
Mexico
Facility Name
Consultorio Medico
City
Zapopan, Jalisco
Country
Mexico
Facility Name
MC Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Catharina-ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
City
Bialystok
Country
Poland
Facility Name
Centrum Medyczne Medur Sp. z o.o.
City
Bielsko-Biala
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
City
Slupsk
Country
Poland
Facility Name
Private Medical Center SRL
City
Arad
Country
Romania
Facility Name
Brasov Emergency Clinical County Hospital
City
Brasov
Country
Romania
Facility Name
"Prof. Dr. Th. Burghele" Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
"Sfantul Ioan" Emergency Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Dinu Uromedica
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute of Uronephrology and Renal Transplantation
City
Bucharest
Country
Romania
Facility Name
PROVITA 2000 Medical Center
City
Constanta
Country
Romania
Facility Name
"Dr. C.I. Parhon" Clinical Hospital
City
Iasi
Country
Romania
Facility Name
Vita Care Flav Medical Center
City
Pitesti
Country
Romania
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
Country
Romania
Facility Name
Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Donetsk Regional Clinical Territorial Medical Association
City
Donetsk
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 Regional Clinical Hospital
City
Odesa
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
City
Zaporizhzhya
Country
Ukraine
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Degarelix Trial in Patients With Prostate Cancer
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