A Degarelix Trial in Patients With Prostate Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Goserelin acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix 240 mg/480 mg	Drug: Degarelix; The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.; Other Names: Firmagon; FE200486
Active Comparator: Goserelin acetate	Drug: Goserelin acetate; The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.; Other Names: Zoladex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin	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.	From baseline to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	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.	From baseline to 3 years
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin	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.	From baseline to 3 years
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin	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.	From baseline to 3 years
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin	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.	From baseline to 3 years
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin	The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.	From baseline to 3 years
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin	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.	Baseline and after 1, 6, 12, 19, and 22 months
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin	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.	Baseline and after 1, 6, 12, 19, and 22 months

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: FE200486 CS35A; 2010-021434-55 (EudraCT Number)