A Degarelix Trial in Patients With Prostate Cancer

This study has been terminated.
(Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01242748
First received: November 16, 2010
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Zoladex
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • PSA level [ Time Frame: Every 3 months during 27 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Testosterone level [ Time Frame: Every three months during 27 months of treatment ] [ Designated as safety issue: No ]
  • Blood sample assessment [ Time Frame: Every 6 months during 27 months of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 288
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. Drug: Degarelix
Active Comparator: B. Drug: Zoladex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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  • Has been withdrawn from the CS35 trial.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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242748

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01242748     History of Changes
Other Study ID Numbers: FE200486 CS35A, 2010-021434-55
Study First Received: November 16, 2010
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014