Status:
TERMINATED
A Degarelix Trial in Patients With Prostate Cancer
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920). In the main CS35 trial, participants were randomised 2:1 to treatment with d...
Eligibility Criteria
Inclusion
- 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
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01242748
Start Date
October 1 2010
End Date
January 1 2012
Last Update
June 3 2015
Active Locations (63)
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1
University of Colorado School of Medicine
Aurora, Colorado, United States
2
The Urology Center of Colorado
Denver, Colorado, United States
3
Urology Associates of Dover, PA
Dover, Delaware, United States
4
South Florida Medical Research
Aventura, Florida, United States