Clinical trial NCT01242748: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 288
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
Secondary outcomes:
measure: Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
measure: Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
measure: Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
measure: Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
measure: Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
timeFrame: From baseline to 3 years
measure: Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
timeFrame: Baseline and after 1, 6, 12, 19, and 22 months
measure: Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
timeFrame: Baseline and after 1, 6, 12, 19, and 22 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Dover
country: United States
facility: Urology Associates of Dover, PA
state: Delaware
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Albuquerque
country: United States
facility: Urology Group of New Mexico, PC
state: New Mexico
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: Urology San Antonio Research, Pa
state: Texas
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Sint-Maarten
city: Brampton
country: Canada
facility: Jonathan Giddens Medicine Professional Corporation
state: Ontario
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Inc.
city: Newmarket
country: Canada
facility: Mor Urology, Inc.
city: Scarborough
country: Canada
facility: Investigational site
city: Toronto
country: Canada
facility: Investigational site
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: Praha
country: Czech Republic
facility: Fakultni nemocnice v Motole, Praha 5
city: Praha
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze, Praha 2
city: Zlin
country: Czech Republic
facility: Krajska nemocnice T. Bati a.s.
city: Oulu
country: Finland
facility: ODL Terveys Oy
city: Tampere
country: Finland
facility: Pohjois-Karjalan keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Kirchheim
country: Germany
facility: Gemeinschaftspraxis Rudolph & Wörner
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: Dombóvár
country: Hungary
facility: Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
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: Chihuahua, Chih.
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Culiacan, Sinaloa
country: Mexico
facility: Hospital Angeles Culiacan
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Mexico City, DF
country: Mexico
facility: Hospital Angeles Lindavista
city: Mexico City
country: Mexico
facility: Médica Sur, S.A.B. de C.V.
city: Zapopan, Jalisco
country: Mexico
facility: Consultorio Medico
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Eindhoven
country: Netherlands
facility: Catharina-ziekenhuis
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: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
city: Arad
country: Romania
facility: Private Medical Center SRL
city: Brasov
country: Romania
facility: Brasov Emergency Clinical County Hospital
city: Bucharest
country: Romania
facility: "Prof. Dr. Th. Burghele" Clinical Hospital
city: Bucharest
country: Romania
facility: "Sfantul Ioan" Emergency Clinical Hospital
city: Bucharest
country: Romania
facility: Dinu Uromedica
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute of Uronephrology and Renal Transplantation
city: Constanta
country: Romania
facility: PROVITA 2000 Medical Center
city: Iasi
country: Romania
facility: "Dr. C.I. Parhon" Clinical Hospital
city: Pitesti
country: Romania
facility: Vita Care Flav Medical Center
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk State Medical Academy
city: Donetsk
country: Ukraine
facility: Donetsk Regional Clinical Territorial Medical Association
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: Ipswich
country: United Kingdom
facility: Ipswich 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: