A Trial of Degarelix in Patients With Prostate Cancer
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
2 other identifiers
interventional
859
14 countries
126
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jun 2009
Shorter than P25 for phase_3 prostate-cancer
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 3, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
June 2, 2014
CompletedJune 2, 2014
May 1, 2014
1.7 years
July 3, 2009
February 14, 2014
May 2, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 3 to Day 364
Secondary Outcomes (4)
Serum Levels of Testosterone Over Time
Baseline and after 1, 2, 3, 6 and 13 months
Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
Baseline and after 1, 2, 3, 6 and 13 months
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
At baseline, 10 months and 13 months
Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
At baseline, 1 month, 4 months, 7 months and 13 months
Study Arms (2)
Degarelix 240 mg/480 mg
EXPERIMENTALGoserelin acetate
ACTIVE COMPARATORInterventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (126)
Urology Centers Of Alabama
Homewood, Alabama, United States
Arkansas Urology
Little Rock, Arkansas, United States
Urology Associates of Central CA
Fresno, California, United States
Medresearch
La Mesa, California, United States
South Orange County Medical Research Center
Laguna Hills, California, United States
Atlantic Urology Medical Group
Long Beach, California, United States
Anschutz Cancer Pavillion
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urological Associates of Bridgeport, P.C.
Trumbull, Connecticut, United States
Urology Associates of Dover, PA
Dover, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
South Florida Medical Research
Aventura, Florida, United States
Florida Foundation for Healthcare Research
Ocala, Florida, United States
Georgis Patsias, MD, PA
Wellington, Florida, United States
Palm Beach Urology Associates, PA
Wellington, Florida, United States
Indiana University Department of Urology
Indianapolis, Indiana, United States
Kansas City Urology Care, PA
Overland Park, Kansas, United States
Urological Associates of Englewood
Englewood, New Jersey, United States
Hamilton Urology PA
Hamilton, New Jersey, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States
Capital Region Urological Surgeons and Research Associates
Albany, New York, United States
Hudson Valley Urology P.C.
Poughkeepsie, New York, United States
Metrolina Urology Clinic
Charlotte, North Carolina, United States
Northeast Urology Research
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
Urologic Consultants of SEPA
Bala-Cynwyd, Pennsylvania, United States
State College Urologic Association
State College, Pennsylvania, United States
Grand Strand Urology
Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas, PA
Dallas, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Urology of Virginia
Norfolk, Virginia, United States
Virginia Urology Center
Richmond, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Seattle Urology Research Center
Burien, Washington, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge - Campus Sint-Maarten
Kortrijk, Belgium
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada
Dr. Cal Andreou Research
Surrey, British Columbia, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada
Dr Gary Steinhoff Clinical Research
Victoria, British Columbia, Canada
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada
Mor Urology, Inc.
Newmarket, Ontario, Canada
Ivestigational site
Scarborough Village, Ontario, Canada
Anthony Skehan Medicine Professionals Corporation
Thunder Bay, Ontario, Canada
Bloor West Professional Center
Toronto, Ontario, Canada
The Health Institute for Men
Toronto, Ontario, Canada
Uro Laval
Laval, Quebec, Canada
Notre Dame Hopital
Montreal, Canada
Urocentrum Brno
Brno, Czechia
Nemocnice Jindrichuv Hradec, a.s.
Jindřichův Hradec, Czechia
Kromerizska nemocnice a.s.
Kroměříž, Czechia
Slezska nemocnice
Opava, Czechia
Fakultni nemocnice v Motole, Praha 5
Prague, Czechia
Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
Prague, Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2
Prague, Czechia
Krajska nemocnice T. Bati a.s.
Zlín, Czechia
Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
Jakobstad, Finland
Pohjois-Karjalan keskussairaala
Joensuu, Finland
ODL Terveys Oy
Oulu, Finland
Tampereen yliopistollinen sairaala
Tampere, Finland
Investigational site
Aachen, Germany
Investigational site
Kirchheim, Germany
Klinikum Mannheim Universitätsklinikum GmbH
Mannheim, Germany
Urologische Studienpraxis
Nürtingen, Germany
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
Budapest, Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Dombóvári Szent Lukács Egészségügyi Kht.
Dombóvár, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
Miskolc, Hungary
Pécsi Tudományegyetem
Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Jávorszky Ödön Kórház
Vác, Hungary
Hospital Christus Muguerza del Parque
Chihuahua City, Chihuahua, Mexico
Hospital Aranda de la Parra , S.A. de C.V.
León, Guanajuato, Mexico
Hospital Angeles Culiacan
Culiacán, Sinaloa, Mexico
Consultorio de Especialidad en Urologia Privado, Durango
Durango, Mexico
Centro Medico Dalinde
Mexico City, Mexico
Hospital Angeles Lindavista
Mexico City, Mexico
Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
Mexico City, Mexico
Consultorio Medico
Zapopan, Jalisco, Mexico
AMC
Amsterdam, Netherlands
Catharina-ziekenhuis
Eindhoven, Netherlands
Atrium MC
Heerlen, Netherlands
MC Haaglanden
The Hague, Netherlands
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
Bialystok, Poland
Centrum Medyczne Medur Sp. z o.o.
Bielsko-Biala, Poland
Gabinet Lekarski
Krakow, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Słupsk, Poland
LexMedica
Wroclaw, Poland
Private Medical Center
Arad, Romania
Brasov Emergency Clinical County Hospital
Brasov, Romania
"Fundeni" Clinical Institute
Bucharest, Romania
"Sfantul Ioan" Emergency Clinical Hospital
Bucharest, Romania
Dinu Uromedica
Bucharest, Romania
Prof. Dr. Th. Burghele Clinical Urology Hospital
Bucharest, Romania
PROVITA 2000 Medical Center
Constanța, Romania
"Dr. C.I. Parhon" Clinical Hospital
Lasi, Romania
Vita Care Flav Medical Center
Piteşti, Romania
Emergency County Clinical Hospital Sibiu
Sibiu, Romania
City Clinical Hospital #60
Moscow, Russia
Moscow State University of Medicine and Dentistry
Moscow, Russia
"Clinic Andros" LLC
Saint Petersburg, Russia
"Orkli" LLC
Saint Petersburg, Russia
City Hospital # 26
Saint Petersburg, Russia
City Hospital #15
Saint Petersburg, Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, Russia
St.Petersburg Multi-Field City Hospital #2
Saint Petersburg, Russia
Regional Clinical Oncology Center
Vladimir, Russia
Municipal Institution "Cherkasy Regional Oncology Dispensary"
Cherkassy, Ukraine
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine
Donetsk Regional Clinical Territorial Medical Association
Donetsk, Ukraine
Ivano-Frankivsk Regional Oncology Dispensary
Ivano-Frankivsk, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
Kharkiv, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, Ukraine
Odesa Regional Clinical Hospital
Odesa, Ukraine
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
Zaporizhzhya, Ukraine
Castle Hill Hospital
Cottingham, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Related Publications (1)
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.
PMID: 34350976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2009
First Posted
July 27, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 2, 2014
Results First Posted
June 2, 2014
Record last verified: 2014-05