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A Trial of Degarelix in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Degarelix
Goserelin acetate
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older.
  • Has a histological confirmed prostate cancer Gleason graded).
  • Has a screening testosterone above 2.2 ng/mL.
  • Rising prostate-specific antigen (PSA).
  • Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
  • Has a life expectancy of at least one year.

Exclusion Criteria:

  • Current or previous hormone therapy.
  • Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
  • Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Has a heart insufficiency.
  • Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
  • Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
  • Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

Sites / Locations

  • Urology Centers Of Alabama
  • Arkansas Urology
  • Urology Associates of Central CA
  • Medresearch
  • South Orange County Medical Research Center
  • Atlantic Urology Medical Group
  • Anschutz Cancer Pavillion
  • The Urology Center of Colorado
  • Urological Associates of Bridgeport, P.C.
  • Urology Associates of Dover, PA
  • Walter Reed Army Medical Center
  • South Florida Medical Research
  • Florida Foundation for Healthcare Research
  • Georgis Patsias, MD, PA
  • Palm Beach Urology Associates, PA
  • Indiana University Department of Urology
  • Kansas City Urology Care, PA
  • Urological Associates of Englewood
  • Hamilton Urology PA
  • Lawrenceville Urology
  • Urology Group of New Mexico, PC
  • Capital Region Urological Surgeons and Research Associates
  • Hudson Valley Urology P.C.
  • Metrolina Urology Clinic
  • Northeast Urology Research
  • Duke University Medical Center
  • Alliance Urology Specialists
  • Urologic Consultants of SEPA
  • State College Urologic Association
  • Grand Strand Urology
  • Urology Clinics of North Texas, PA
  • Urology San Antonio Research
  • Urology of Virginia
  • Virginia Urology Center
  • Urology of Virginia
  • Seattle Urology Research Center
  • Cliniques Universitaires Saint-Luc
  • UZ Antwerpen
  • UZ Gent
  • AZ Groeninge - Campus Sint-Maarten
  • Southern Interior Medical Research Inc.
  • Dr. Cal Andreou Research
  • Can-Med Clinical Research Inc.
  • Dr Gary Steinhoff Clinical Research
  • Bramalea Medical Centre
  • Urology Associates / Urologic Medical Research
  • Mor Urology, Inc.
  • Ivestigational site
  • Anthony Skehan Medicine Professionals Corporation
  • Bloor West Professional Center
  • The Health Institute for Men
  • Uro Laval
  • Notre Dame Hopital
  • Urocentrum Brno
  • Nemocnice Jindrichuv Hradec, a.s.
  • Kromerizska nemocnice a.s.
  • Slezska nemocnice
  • Fakultni nemocnice v Motole, Praha 5
  • Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
  • Vseobecna fakultni nemocnice v Praze, Praha 2
  • Krajska nemocnice T. Bati a.s.
  • Pohjois-Karjalan keskussairaala
  • ODL Terveys Oy
  • Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
  • Tampereen yliopistollinen sairaala
  • Investigational site
  • Investigational site
  • Klinikum Mannheim Universitätsklinikum GmbH
  • Urologische Studienpraxis
  • Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
  • Fövárosi Önkormányzat uzsoki utcai Kórház
  • Semmelweis Egyetem
  • Dombóvári Szent Lukács Egészségügyi Kht.
  • 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 Aranda de la Parra , S.A. de C.V.
  • Hospital Angeles Culiacan
  • Hospital Christus Muguerza del Parque
  • Consultorio de Especialidad en Urologia Privado, Durango
  • Centro Medico Dalinde
  • Hospital Angeles Lindavista
  • Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
  • Consultorio Medico
  • AMC
  • MC Haaglanden
  • Catharina-ziekenhuis
  • Atrium MC
  • SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
  • Centrum Medyczne Medur Sp. z o.o.
  • Gabinet Lekarski
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
  • LexMedica
  • Private Medical Center
  • Brasov Emergency Clinical County Hospital
  • "Fundeni" Clinical Institute
  • "Sfantul Ioan" Emergency Clinical Hospital
  • Dinu Uromedica
  • Prof. Dr. Th. Burghele Clinical Urology Hospital
  • PROVITA 2000 Medical Center
  • "Dr. C.I. Parhon" Clinical Hospital
  • Vita Care Flav Medical Center
  • Emergency County Clinical Hospital Sibiu
  • City Clinical Hospital #60
  • Moscow State University of Medicine and Dentistry
  • "Clinic Andros" LLC
  • "Orkli" LLC
  • City Hospital # 26
  • City Hospital #15
  • St. Petersburg State Medical University n.a. I.P. Pavlov
  • St.Petersburg Multi-Field City Hospital #2
  • Regional Clinical Oncology Center
  • Municipal Institution "Cherkasy Regional Oncology Dispensary"
  • Dnipropetrovsk State Medical Academy
  • Donetsk Regional Clinical Territorial Medical Association
  • Ivano-Frankivsk Regional Oncology Dispensary
  • 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"
  • Castle Hill Hospital
  • Ipswich Hospital
  • Royal Liverpool University 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

Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.

Secondary Outcome Measures

Serum Levels of Testosterone Over Time
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.

Full Information

First Posted
July 3, 2009
Last Updated
May 2, 2014
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00946920
Brief Title
A Trial of Degarelix in Patients With Prostate Cancer
Official Title
An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 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
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

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
Randomized
Enrollment
859 (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. 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).
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. 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).
Primary Outcome Measure Information:
Title
Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
Description
This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Time Frame
From Day 28 to Day 364
Title
Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
Description
This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.
Time Frame
Day 3 to Day 364
Secondary Outcome Measure Information:
Title
Serum Levels of Testosterone Over Time
Description
Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.
Time Frame
Baseline and after 1, 2, 3, 6 and 13 months
Title
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Description
Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.
Time Frame
Baseline and after 1, 2, 3, 6 and 13 months
Title
Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline
Description
The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Time Frame
At baseline, 10 months and 13 months
Title
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
Description
IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and a score of 5 corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia.
Time Frame
At baseline, 1 month, 4 months, 7 months and 13 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older. Has a histological confirmed prostate cancer Gleason graded). Has a screening testosterone above 2.2 ng/mL. Rising prostate-specific antigen (PSA). Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2. Has a life expectancy of at least one year. Exclusion Criteria: Current or previous hormone therapy. Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening. Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. Has a heart insufficiency. Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years. Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator. Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial. Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
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
Arkansas Urology
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Urology Associates of Central CA
City
Fresno
State/Province
California
Country
United States
Facility Name
Medresearch
City
La Mesa
State/Province
California
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
Atlantic Urology Medical Group
City
Long Beach
State/Province
California
Country
United States
Facility Name
Anschutz Cancer Pavillion
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
Urological Associates of Bridgeport, P.C.
City
Trumbull
State/Province
Connecticut
Country
United States
Facility Name
Urology Associates of Dover, PA
City
Dover
State/Province
Delaware
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Georgis Patsias, MD, PA
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Palm Beach Urology Associates, PA
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Indiana University Department of Urology
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Kansas City Urology Care, PA
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Urological Associates of Englewood
City
Englewood
State/Province
New Jersey
Country
United States
Facility Name
Hamilton Urology PA
City
Hamilton
State/Province
New Jersey
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Urology Group of New Mexico, PC
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Capital Region Urological Surgeons and Research Associates
City
Albany
State/Province
New York
Country
United States
Facility Name
Hudson Valley Urology P.C.
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Metrolina Urology Clinic
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Alliance Urology Specialists
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Urologic Consultants of SEPA
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
State College Urologic Association
City
State College
State/Province
Pennsylvania
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Urology Clinics of North Texas, PA
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Urology of Virginia
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Virginia Urology Center
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Seattle Urology Research Center
City
Burien
State/Province
Washington
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
AZ Groeninge - Campus Sint-Maarten
City
Kortrijk
Country
Belgium
Facility Name
Southern Interior Medical Research Inc.
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Dr. Cal Andreou Research
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Can-Med Clinical Research Inc.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Dr Gary Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Bramalea Medical Centre
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Urology Associates / Urologic Medical Research
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Mor Urology, Inc.
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Ivestigational site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Anthony Skehan Medicine Professionals Corporation
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Bloor West Professional Center
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
The Health Institute for Men
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Uro Laval
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Notre Dame Hopital
City
Montreal
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
Slezska nemocnice
City
Opava
Country
Czech Republic
Facility Name
Fakultni nemocnice v Motole, Praha 5
City
Prague
Country
Czech Republic
Facility Name
Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
City
Prague
Country
Czech Republic
Facility Name
Vseobecna fakultni nemocnice v Praze, Praha 2
City
Prague
Country
Czech Republic
Facility Name
Krajska nemocnice T. Bati a.s.
City
Zlin
Country
Czech Republic
Facility Name
Pohjois-Karjalan keskussairaala
City
Joensuu
Country
Finland
Facility Name
ODL Terveys Oy
City
Oulu
Country
Finland
Facility Name
Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
City
Pietarsaari
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
Country
Finland
Facility Name
Investigational site
City
Aachen
Country
Germany
Facility Name
Investigational site
City
Kirchheim
Country
Germany
Facility Name
Klinikum Mannheim Universitätsklinikum GmbH
City
Mannheim
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 Kht.
City
Dombovar
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 Aranda de la Parra , S.A. de C.V.
City
Leon
State/Province
GTO
Country
Mexico
Facility Name
Hospital Angeles Culiacan
City
Culiacan
State/Province
Sinaloa
Country
Mexico
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua
Country
Mexico
Facility Name
Consultorio de Especialidad en Urologia Privado, Durango
City
Durango
Country
Mexico
Facility Name
Centro Medico Dalinde
City
Mexico City
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Mexico City
Country
Mexico
Facility Name
Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
City
Mexico City
Country
Mexico
Facility Name
Consultorio Medico
City
Zapopan, Jalisco
Country
Mexico
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
MC Haaglanden
City
Den Haag
Country
Netherlands
Facility Name
Catharina-ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Atrium MC
City
Heerlen
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
Gabinet Lekarski
City
Krakow
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
City
Slupsk
Country
Poland
Facility Name
LexMedica
City
Wroclaw
Country
Poland
Facility Name
Private Medical Center
City
Arad
Country
Romania
Facility Name
Brasov Emergency Clinical County Hospital
City
Brasov
Country
Romania
Facility Name
"Fundeni" Clinical Institute
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
Prof. Dr. Th. Burghele Clinical Urology Hospital
City
Bucharest
Country
Romania
Facility Name
PROVITA 2000 Medical Center
City
Constanta
Country
Romania
Facility Name
"Dr. C.I. Parhon" Clinical Hospital
City
Lasi
Country
Romania
Facility Name
Vita Care Flav Medical Center
City
Pitesti
Country
Romania
Facility Name
Emergency County Clinical Hospital Sibiu
City
Sibiu
Country
Romania
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
"Clinic Andros" LLC
City
St. Petersburg
Country
Russian Federation
Facility Name
"Orkli" LLC
City
St. Petersburg
Country
Russian Federation
Facility Name
City Hospital # 26
City
St. Petersburg
Country
Russian Federation
Facility Name
City Hospital #15
City
St. Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State Medical University n.a. I.P. Pavlov
City
St. Petersburg
Country
Russian Federation
Facility Name
St.Petersburg Multi-Field City Hospital #2
City
St. Petersburg
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Vladimir
Country
Russian Federation
Facility Name
Municipal Institution "Cherkasy Regional Oncology Dispensary"
City
Cherkassy
Country
Ukraine
Facility Name
Dnipropetrovsk State Medical Academy
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Donetsk Regional Clinical Territorial Medical Association
City
Donetsk
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Oncology Dispensary
City
Ivano-Frankivsk
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
Castle Hill Hospital
City
Cottingham
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
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 Trial of Degarelix in Patients With Prostate Cancer

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