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  • Has been withdrawn from the CS35 trial.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

  Show 63 Study Locations
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

ClinicalTrials.gov processed this record on October 16, 2014