A Degarelix Trial in Patients With Prostate Cancer

Phase 3

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Goserelin acetate
Drug: Degarelix

Registration Number: NCT01242748

Lead Sponsor: Ferring Pharmaceuticals

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 288

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Has been withdrawn from the CS35 trial.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.

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
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin	From baseline to 3 years	PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

Secondary Outcome Measures

Name	Time	Method
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	From baseline to 3 years	PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	From baseline to 3 years	PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin	From baseline to 3 years	Testosterone escape is defined as serum levels \>0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin	From baseline to 3 years	Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin	From baseline to 3 years	The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin	Baseline and after 1, 6, 12, 19, and 22 months	Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin	Baseline and after 1, 6, 12, 19, and 22 months	Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

Trial Locations

Locations (62): Urology Associates of Dover, PA
🇺🇸
Dover, Delaware, United States
Vseobecna fakultni nemocnice v Praze, Praha 2
🇨🇿
Praha, Czech Republic
Pohjois-Karjalan keskussairaala
🇫🇮
Tampere, Finland
Sibiu Emergency Clinical County Hospital
🇷🇴
Sibiu, Romania
Odesa Regional Clinical Hospital
🇺🇦
Odesa, Ukraine
The Urology Center of Colorado
🇺🇸
Denver, Colorado, United States
University of Colorado School of Medicine
🇺🇸
Aurora, Colorado, United States
Seattle Urology Research Center
🇺🇸
Burien, Washington, United States
Mor Urology, Inc.
🇨🇦
Newmarket, Canada
Southern Interior Medical Research Inc.
🇨🇦
Kelowna, Canada
Urocentrum Brno
🇨🇿
Brno, Czech Republic
Investigational site
🇨🇦
Toronto, Canada
Nemocnice Jindrichuv Hradec, a.s.
🇨🇿
Jindrichuv Hradec, Czech Republic
Kromerizska nemocnice a.s.
🇨🇿
Kromeriz, Czech Republic
Fakultni nemocnice v Motole, Praha 5
🇨🇿
Praha, Czech Republic
Krajska nemocnice T. Bati a.s.
🇨🇿
Zlin, Czech Republic
ODL Terveys Oy
🇫🇮
Oulu, Finland
Gemeinschaftspraxis Rudolph & Wörner
🇩🇪
Kirchheim, Germany
Tampereen yliopistollinen sairaala
🇫🇮
Tampere, Finland
Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
🇭🇺
Budapest, Hungary
Urologische Studienpraxis
🇩🇪
Nürtingen, Germany
Fövárosi Önkormányzat uzsoki utcai Kórház
🇭🇺
Budapest, Hungary
Semmelweis Egyetem
🇭🇺
Budapest, Hungary
Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
🇭🇺
Dombóvár, Hungary
Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
🇭🇺
Miskolc, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
🇭🇺
Miskolc, Hungary
Fundeni Clinical Institute of Uronephrology and Renal Transplantation
🇷🇴
Bucharest, Romania
Dnipropetrovsk State Medical Academy
🇺🇦
Dnipropetrovsk, Ukraine
Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
🇺🇦
Kharkiv, Ukraine
Donetsk Regional Clinical Territorial Medical Association
🇺🇦
Donetsk, Ukraine
The Royal Marsden NHS Foundation Trust
🇬🇧
Sutton, United Kingdom
South Florida Medical Research
🇺🇸
Aventura, Florida, United States
Pécsi Tudományegyetem
🇭🇺
Pécs, Hungary
AZ Groeninge - Campus Sint-Maarten
🇧🇪
Kortrijk, Belgium
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺
Szeged, Hungary
Jávorszky Ödön Kórház
🇭🇺
Vác, Hungary
Hospital Christus Muguerza del Parque
🇲🇽
Chihuahua, Chih., Mexico
Consultorio de Especialidad en Urologia Privado
🇲🇽
Durango, Mexico
Médica Sur, S.A.B. de C.V.
🇲🇽
Mexico City, Mexico
Centrum Medyczne Medur Sp. z o.o.
🇵🇱
Bielsko-Biala, Poland
Private Medical Center SRL
🇷🇴
Arad, Romania
Brasov Emergency Clinical County Hospital
🇷🇴
Brasov, Romania
Jonathan Giddens Medicine Professional Corporation
🇨🇦
Brampton, Ontario, Canada
MC Haaglanden
🇳🇱
Den Haag, Netherlands
Catharina-ziekenhuis
🇳🇱
Eindhoven, Netherlands
SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
🇵🇱
Bialystok, Poland
"Prof. Dr. Th. Burghele" Clinical Hospital
🇷🇴
Bucharest, Romania
Hospital Angeles Lindavista
🇲🇽
Mexico City, DF, Mexico
Hospital Angeles Culiacan
🇲🇽
Culiacan, Sinaloa, Mexico
Consultorio Medico
🇲🇽
Zapopan, Jalisco, Mexico
"Sfantul Ioan" Emergency Clinical Hospital
🇷🇴
Bucharest, Romania
"Dr. C.I. Parhon" Clinical Hospital
🇷🇴
Iasi, Romania
PROVITA 2000 Medical Center
🇷🇴
Constanta, Romania
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
🇵🇱
Slupsk, Poland
Vita Care Flav Medical Center
🇷🇴
Pitesti, Romania
Dinu Uromedica
🇷🇴
Bucharest, Romania
Kyiv City Clinical Hospital #3
🇺🇦
Kyiv, Ukraine
Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
🇺🇦
Zaporizhzhya, Ukraine
Ipswich Hospital
🇬🇧
Ipswich, United Kingdom
Urology Group of New Mexico, PC
🇺🇸
Albuquerque, New Mexico, United States
Carolina Urologic Research Center
🇺🇸
Myrtle Beach, South Carolina, United States
Urology San Antonio Research, Pa
🇺🇸
San Antonio, Texas, United States