Clinical trial NCT00946920: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 859
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
timeFrame: From Day 28 to Day 364
measure: Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin
timeFrame: Day 3 to Day 364
Secondary outcomes:
measure: Serum Levels of Testosterone Over Time
timeFrame: Baseline and after 1, 2, 3, 6 and 13 months
measure: Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time
timeFrame: Baseline and after 1, 2, 3, 6 and 13 months
measure: 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
timeFrame: At baseline, 10 months and 13 months
measure: Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline
timeFrame: At baseline, 1 month, 4 months, 7 months and 13 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Fresno
country: United States
facility: Urology Associates of Central CA
state: California
city: La Mesa
country: United States
facility: Medresearch
state: California
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavillion
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Trumbull
country: United States
facility: Urological Associates of Bridgeport, P.C.
state: Connecticut
city: Dover
country: United States
facility: Urology Associates of Dover, PA
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Wellington
country: United States
facility: Georgis Patsias, MD, PA
state: Florida
city: Wellington
country: United States
facility: Palm Beach Urology Associates, PA
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Department of Urology
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Urology Care, PA
state: Kansas
city: Englewood
country: United States
facility: Urological Associates of Englewood
state: New Jersey
city: Hamilton
country: United States
facility: Hamilton Urology PA
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico, PC
state: New Mexico
city: Albany
country: United States
facility: Capital Region Urological Surgeons and Research Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology P.C.
state: New York
city: Charlotte
country: United States
facility: Metrolina Urology Clinic
state: North Carolina
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SEPA
state: Pennsylvania
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PA
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Norfolk
country: United States
facility: Urology of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Sint-Maarten
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Cal Andreou Research
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Dr Gary Steinhoff Clinical Research
state: British Columbia
city: Brampton
country: Canada
facility: Bramalea Medical Centre
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates / Urologic Medical Research
state: Ontario
city: Newmarket
country: Canada
facility: Mor Urology, Inc.
state: Ontario
city: Scarborough
country: Canada
facility: Ivestigational site
state: Ontario
city: Thunder Bay
country: Canada
facility: Anthony Skehan Medicine Professionals Corporation
state: Ontario
city: Toronto
country: Canada
facility: Bloor West Professional Center
state: Ontario
city: Toronto
country: Canada
facility: The Health Institute for Men
state: Ontario
city: Laval
country: Canada
facility: Uro Laval
state: Quebec
city: Montreal
country: Canada
facility: Notre Dame Hopital
city: Brno
country: Czech Republic
facility: Urocentrum Brno
city: Jindrichuv Hradec
country: Czech Republic
facility: Nemocnice Jindrichuv Hradec, a.s.
city: Kromeriz
country: Czech Republic
facility: Kromerizska nemocnice a.s.
city: Opava
country: Czech Republic
facility: Slezska nemocnice
city: Prague
country: Czech Republic
facility: Fakultni nemocnice v Motole, Praha 5
city: Prague
country: Czech Republic
facility: Fakultni Thomayerova nemocnice s poliklinikou, Praha 4
city: Prague
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze, Praha 2
city: Zlin
country: Czech Republic
facility: Krajska nemocnice T. Bati a.s.
city: Joensuu
country: Finland
facility: Pohjois-Karjalan keskussairaala
city: Oulu
country: Finland
facility: ODL Terveys Oy
city: Pietarsaari
country: Finland
facility: Pietarsaaren sairaala/ Malmin terveydenhuoltoalue
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Aachen
country: Germany
facility: Investigational site
city: Kirchheim
country: Germany
facility: Investigational site
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitätsklinikum GmbH
city: Nürtingen
country: Germany
facility: Urologische Studienpraxis
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat uzsoki utcai Kórház
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Dombovar
country: Hungary
facility: Dombóvári Szent Lukács Egészségügyi Kht.
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra , S.A. de C.V.
state: GTO
city: Culiacan
country: Mexico
facility: Hospital Angeles Culiacan
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado, Durango
city: Mexico City
country: Mexico
facility: Centro Medico Dalinde
city: Mexico City
country: Mexico
facility: Hospital Angeles Lindavista
city: Mexico City
country: Mexico
facility: Operadora MSB, S.A. de C.V. (Medica Sur CIF-BIOTEC)
city: Zapopan, Jalisco
country: Mexico
facility: Consultorio Medico
city: Amsterdam
country: Netherlands
facility: AMC
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Eindhoven
country: Netherlands
facility: Catharina-ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Bialystok
country: Poland
facility: SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
city: Bielsko-Biala
country: Poland
facility: Centrum Medyczne Medur Sp. z o.o.
city: Krakow
country: Poland
facility: Gabinet Lekarski
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
city: Wroclaw
country: Poland
facility: LexMedica
city: Arad
country: Romania
facility: Private Medical Center
city: Brasov
country: Romania
facility: Brasov Emergency Clinical County Hospital
city: Bucharest
country: Romania
facility: "Fundeni" Clinical Institute
city: Bucharest
country: Romania
facility: "Sfantul Ioan" Emergency Clinical Hospital
city: Bucharest
country: Romania
facility: Dinu Uromedica
city: Bucharest
country: Romania
facility: Prof. Dr. Th. Burghele Clinical Urology Hospital
city: Constanta
country: Romania
facility: PROVITA 2000 Medical Center
city: Lasi
country: Romania
facility: "Dr. C.I. Parhon" Clinical Hospital
city: Pitesti
country: Romania
facility: Vita Care Flav Medical Center
city: Sibiu
country: Romania
facility: Emergency County Clinical Hospital Sibiu
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #60
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
city: St. Petersburg
country: Russian Federation
facility: "Clinic Andros" LLC
city: St. Petersburg
country: Russian Federation
facility: "Orkli" LLC
city: St. Petersburg
country: Russian Federation
facility: City Hospital # 26
city: St. Petersburg
country: Russian Federation
facility: City Hospital #15
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n.a. I.P. Pavlov
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg Multi-Field City Hospital #2
city: Vladimir
country: Russian Federation
facility: Regional Clinical Oncology Center
city: Cherkassy
country: Ukraine
facility: Municipal Institution "Cherkasy Regional Oncology Dispensary"
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk State Medical Academy
city: Donetsk
country: Ukraine
facility: Donetsk Regional Clinical Territorial Medical Association
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Oncology Dispensary
city: Kharkiv
country: Ukraine
facility: Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.