Expired Study
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Homewood, Alabama 35209


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

FE200486 CS30


NCT ID:

NCT00833248


Secondary ID:

2008-005232-33 (EudraCT N


Study Acronym:


Brief Title:

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer


Official Title:

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 Hormo


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ferring Pharmaceuticals


Oversight Authority:

  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • Germany: Federal Institute for Drugs and Medical Devices
  • Spain: Spanish Agency of Medicines
  • France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
  • Greece: National Organization of Medicines
  • Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

246


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Development Support
Study Director
Ferring Pharmaceuticals

Study Dates

Start Date:April 2009
Completion Date:October 2011
Completion Type:Actual
Primary Completion Date:September 2011
Primary Completion Type:Actual
Verification Date:December 2011
Last Changed Date:December 8, 2011
First Received Date:January 30, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety (Adverse events and laboratory values)
Time Frame:As applicable
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Evaluate patients' Quality of life based on questionnaire
Time Frame:After 4, 8 and 12 weeks treatment compared to baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate changes in the concentration of oestradiol in the serum (blood)
Time Frame:After 4, 8 and 12 weeks treatment compared to baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate changes in the concentration of testosterone in the serum
Time Frame:After 4, 8 and 12 weeks treatment compared to Baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:LUTS relief based on reduction in IPSS (questionnaire)
Time Frame:After 4, 8 and 12 weeks treatment compared to Baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Mean percentage reduction in prostate volume
Time Frame:After 12 weeks treatment compared to Baseline
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Degarelix
Description:Treatment with Degarelix for 3 months
Arm Name:Degarelix
Other Name:degarelix acetate
Intervention Type:Drug
Name:Goserelin (Zoladex®) combined with anti-androgen f
Description:Treatment for three months
Arm Name:Goserelin and bicalutamide
Other Name:Zoladex®

Study Arms

Study Arm Type:Active Comparator
Arm Name:Goserelin and bicalutamide
Study Arm Type:Experimental
Arm Name:Degarelix

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ferring Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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