A Trial of Degarelix in Patients With Prostate Cancer
- Registration Number
- NCT00946920
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 859
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Goserelin acetate Goserelin acetate - Degarelix 240 mg/480 mg Degarelix -
- Primary Outcome Measures
Name Time Method Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix From Day 28 to Day 364 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 Day 3 to Day 364 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
Name Time Method Serum Levels of Testosterone Over Time Baseline and after 1, 2, 3, 6 and 13 months 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 Baseline and after 1, 2, 3, 6 and 13 months 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 At baseline, 10 months and 13 months 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 At baseline, 1 month, 4 months, 7 months and 13 months 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.
Related Research Topics
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Trial Locations
- Locations (124)
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Palm Beach Urology Associates, PA
🇺🇸Wellington, Florida, United States
UZ Gent
🇧🇪Gent, Belgium
Ivestigational site
🇨🇦Scarborough, Ontario, Canada
Bloor West Professional Center
🇨🇦Toronto, Ontario, Canada
Atrium MC
🇳🇱Heerlen, Netherlands
Urocentrum Brno
🇨🇿Brno, Czech Republic
Slezska nemocnice
🇨🇿Opava, Czech Republic
Urologische Studienpraxis
🇩🇪Nürtingen, Germany
Gabinet Lekarski
🇵🇱Krakow, Poland
St. Petersburg State Medical University n.a. I.P. Pavlov
🇷🇺St. Petersburg, Russian Federation
Dnipropetrovsk State Medical Academy
🇺🇦Dnipropetrovsk, Ukraine
City Clinical Hospital #60
🇷🇺Moscow, Russian Federation
Brasov Emergency Clinical County Hospital
🇷🇴Brasov, Romania
St.Petersburg Multi-Field City Hospital #2
🇷🇺St. Petersburg, Russian Federation
Donetsk Regional Clinical Territorial Medical Association
🇺🇦Donetsk, Ukraine
Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
🇺🇦Zaporizhzhya, Ukraine
Atlantic Urology Medical Group
🇺🇸Long Beach, California, United States
Regional Clinical Oncology Center
🇷🇺Vladimir, Russian Federation
Kyiv City Clinical Hospital #3
🇺🇦Kyiv, Ukraine
"Orkli" LLC
🇷🇺St. Petersburg, Russian Federation
City Hospital # 26
🇷🇺St. Petersburg, Russian Federation
Ivano-Frankivsk Regional Oncology Dispensary
🇺🇦Ivano-Frankivsk, Ukraine
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
City Hospital #15
🇷🇺St. Petersburg, Russian Federation
Municipal Institution "Cherkasy Regional Oncology Dispensary"
🇺🇦Cherkassy, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
🇺🇦Kharkiv, Ukraine
Kansas City Urology Care, PA
🇺🇸Overland Park, Kansas, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Hospital Angeles Culiacan
🇲🇽Culiacan, Sinaloa, Mexico
Anschutz Cancer Pavillion
🇺🇸Aurora, Colorado, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Hospital Angeles Lindavista
🇲🇽Mexico City, Mexico
Consultorio Medico
🇲🇽Zapopan, Jalisco, Mexico
Urology Centers Of Alabama
🇺🇸Homewood, Alabama, United States
Urology Associates of Central CA
🇺🇸Fresno, California, 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, 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
Indiana University Department of Urology
🇺🇸Indianapolis, Indiana, United States
Urological Associates of Englewood
🇺🇸Englewood, New Jersey, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
Hamilton Urology PA
🇺🇸Hamilton, New Jersey, United States
Urology Group of New Mexico, PC
🇺🇸Albuquerque, New Mexico, United States
Metrolina Urology Clinic
🇺🇸Charlotte, North Carolina, United States
Urologic Consultants of SEPA
🇺🇸Bala Cynwyd, Pennsylvania, United States
Alliance Urology Specialists
🇺🇸Greensboro, North Carolina, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
State College Urologic Association
🇺🇸State College, Pennsylvania, United States
Urology Clinics of North Texas, PA
🇺🇸Dallas, Texas, United States
Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
Seattle Urology Research Center
🇺🇸Burien, Washington, United States
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
Dr. Cal Andreou Research
🇨🇦Surrey, British Columbia, Canada
AZ Groeninge - Campus Sint-Maarten
🇧🇪Kortrijk, Belgium
Southern Interior Medical Research Inc.
🇨🇦Kelowna, British Columbia, Canada
Can-Med Clinical Research Inc.
🇨🇦Victoria, British Columbia, Canada
Dr Gary Steinhoff Clinical Research
🇨🇦Victoria, British Columbia, Canada
Urology Associates / Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
The Health Institute for Men
🇨🇦Toronto, Ontario, Canada
Anthony Skehan Medicine Professionals Corporation
🇨🇦Thunder Bay, Ontario, Canada
Mor Urology, Inc.
🇨🇦Newmarket, Ontario, Canada
Uro Laval
🇨🇦Laval, Quebec, Canada
Notre Dame Hopital
🇨🇦Montreal, Canada
Nemocnice Jindrichuv Hradec, a.s.
🇨🇿Jindrichuv Hradec, Czech Republic
Fakultni nemocnice v Motole, Praha 5
🇨🇿Prague, Czech Republic
Kromerizska nemocnice a.s.
🇨🇿Kromeriz, Czech Republic
Vseobecna fakultni nemocnice v Praze, Praha 2
🇨🇿Prague, Czech Republic
Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
🇨🇿Prague, Czech Republic
Pohjois-Karjalan keskussairaala
🇫🇮Joensuu, Finland
Krajska nemocnice T. Bati a.s.
🇨🇿Zlin, Czech Republic
ODL Terveys Oy
🇫🇮Oulu, Finland
Pécsi Tudományegyetem
🇭🇺Pécs, Hungary
Investigational site
🇩🇪Kirchheim, Germany
Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
🇫🇮Pietarsaari, Finland
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Finland
Klinikum Mannheim Universitätsklinikum GmbH
🇩🇪Mannheim, Germany
Fövárosi Önkormányzat uzsoki utcai Kórház
🇭🇺Budapest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
🇭🇺Budapest, Hungary
Dombóvári Szent Lukács Egészségügyi Kht.
🇭🇺Dombovar, 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
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
Jávorszky Ödön Kórház
🇭🇺Vác, Hungary
Centro Medico Dalinde
🇲🇽Mexico City, Mexico
Hospital Aranda de la Parra , S.A. de C.V.
🇲🇽Leon, GTO, Mexico
Hospital Christus Muguerza del Parque
🇲🇽Chihuahua, Mexico
Consultorio de Especialidad en Urologia Privado, Durango
🇲🇽Durango, Mexico
AMC
🇳🇱Amsterdam, Netherlands
Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
🇲🇽Mexico City, Mexico
MC Haaglanden
🇳🇱Den Haag, Netherlands
Catharina-ziekenhuis
🇳🇱Eindhoven, Netherlands
Centrum Medyczne Medur Sp. z o.o.
🇵🇱Bielsko-Biala, Poland
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
🇵🇱Bialystok, Poland
"Fundeni" Clinical Institute
🇷🇴Bucharest, Romania
Private Medical Center
🇷🇴Arad, Romania
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
🇵🇱Slupsk, Poland
LexMedica
🇵🇱Wroclaw, Poland
"Sfantul Ioan" Emergency Clinical Hospital
🇷🇴Bucharest, Romania
Dinu Uromedica
🇷🇴Bucharest, Romania
Emergency County Clinical Hospital Sibiu
🇷🇴Sibiu, Romania
Prof. Dr. Th. Burghele Clinical Urology Hospital
🇷🇴Bucharest, Romania
PROVITA 2000 Medical Center
🇷🇴Constanta, Romania
Vita Care Flav Medical Center
🇷🇴Pitesti, Romania
"Dr. C.I. Parhon" Clinical Hospital
🇷🇴Lasi, Romania
Moscow State University of Medicine and Dentistry
🇷🇺Moscow, Russian Federation
"Clinic Andros" LLC
🇷🇺St. Petersburg, Russian Federation
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Hudson Valley Urology P.C.
🇺🇸Poughkeepsie, New York, United States
Virginia Urology Center
🇺🇸Richmond, Virginia, United States
Capital Region Urological Surgeons and Research Associates
🇺🇸Albany, New York, United States
Medresearch
🇺🇸La Mesa, California, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Bramalea Medical Centre
🇨🇦Brampton, Ontario, Canada
South Orange County Medical Research Center
🇺🇸Laguna Hills, California, United States
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom