Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00801242
First received: December 2, 2008
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this trial is to see how well a new trial drug (degarelix) works and how safe it is when given for 7 months. For patients participating, their level of PSA (prostate specific antigen) will be measured in a blood sample, and when this level rises above a certain level they will receive treatment for the prostate cancer again. The patients will come to the clinic at monthly intervals for the first 7 months and after this they will be followed bi-monthly for a period of up to 24 months.


Condition Intervention Phase
Prostate Cancer
Drug: degarelix
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles 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:
  • Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the time to PSA > 4 ng/mL in patient subgroups. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Evaluate the time to testosterone > 0,5 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Evaluate the degarelix plasma levels [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: December 2008
Study Completion Date: July 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: degarelix Drug: degarelix
One starting dose of 240 mg; followed by monthly maintenance doses of 80 mg for 7 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has given written informed consent before any trial-related activity is performed.
  • Has prostate cancer, and is in need of this type of treatment.

Exclusion Criteria:

  • Has had previous or is currently under hormonal treatment of prostate cancer.
  • Is considered to be candidate for radical prostatectomy or radiotherapy.
  • Has a history of severe uncontrolled asthma and/or other severe allergic reactions.
  • Has hypersensitivity towards any component of degarelix.
  • Has had cancer within the last five years except prostate cancer and some types of skin cancer.
  • Has a severe disorder (other than prostate cancer) including but not limited to liver, biliary, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, as judged by the investigator.
  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: NCT00801242

  Show 52 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: NCT00801242     History of Changes
Other Study ID Numbers: FE200486 CS29, EudraCT No: 2008-003931-19
Study First Received: December 2, 2008
Last Updated: July 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: National Consultative Ethics Committee for Health and Life Sciences
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Spain: Spanish Agency of Medicines
Spain: Comité Ético de Investigación Clínica
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

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 July 28, 2014