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Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
This study is currently recruiting participants.
Study NCT00801242   Information provided by Ferring Pharmaceuticals
First Received: December 2, 2008   Last Updated: September 7, 2009   History of Changes

December 2, 2008
September 7, 2009
December 2008
November 2012   (final data collection date for primary outcome measure)
Evaluate the time to PSA > 4 ng/mL [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00801242 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer
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

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.

 
Phase III
Interventional
Treatment, Open Label, Single Group Assignment, Efficacy Study
Prostate Cancer
Drug: degarelix
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
January 2013
November 2012   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact: Clinical Development Support DK0-Disclosure@ferring.com
Belgium,   France,   Germany,   Italy,   Netherlands,   Spain
 
NCT00801242
Hjort, Director, Ferring Pharmaceuticals
FE200486 CS29, EudraCT No: 2008-003931-19
Ferring Pharmaceuticals
 
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP