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Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
This study is currently recruiting participants.
Study NCT00833248   Information provided by Ferring Pharmaceuticals
First Received: January 30, 2009   Last Updated: October 8, 2009   History of Changes

January 30, 2009
October 8, 2009
April 2009
April 2010   (final data collection date for primary outcome measure)
Mean percentage reduction in prostate volume [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833248 on ClinicalTrials.gov Archive Site
  • LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After 4, 8 and 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Evaluate changes in the concentration of testosterone in the serum [ Time Frame: After 4, 8 and 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Evaluate changes in the concentration of Prostate Specific Antigen (PSA) in the serum [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
  • Evaluate changes in the concentration of oestradiol in the serum (blood) [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
  • Evaluate patients' Quality of life based on questionnaire [ Time Frame: After 4, 8 and 12 weeks treatment compared to baseline ] [ Designated as safety issue: No ]
  • Safety (Adverse events and laboratory values) [ Time Frame: As applicable ] [ Designated as safety issue: Yes ]
Same as current
 
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)

The purpose of this trial is to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who are scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, hormone therapy will be given for three months and patients will be randomly selected (like flipping a coin) to receive either Degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide) The prostate size will be measured by ultra sound at the beginning and at the end of the trial and patients will be required to come to the clinic for 5 or 6 visits during the three months.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Prostate Cancer
  • Drug: Degarelix
  • Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
August 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has given written informed consent before any trial-related activity is performed.
  • Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

  • Previous treatment for prostate cancer
  • Previous trans-urethral resection of the prostate
  • Patients who are lymph node positive or have other metastatic disease
  • Use of urethral catheter
  • Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
  • History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Hypersensitivity towards any component of the investigational product
  • Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
  • Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
  • Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Male
18 Years and older
No
Contact: Clinical Development Support DK0-Disclosure@ferring.com
France,   Germany,   Greece,   Netherlands,   Spain,   United Kingdom
 
NCT00833248
Hjort, Director, Ferring Pharmaceuticals
FE200486 CS30, 2008-005232-33 (EudraCT No)
Ferring Pharmaceuticals
 
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
October 2009

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