An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Inclusion Criteria:
- 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 Criteria:
- Has been withdrawn from the CS35 trial.
- Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PSA level
Outcome Time Frame:
Every 3 months during 27 months of treatment
Safety Issue:
Yes
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
FE200486 CS35A
NCT ID:
NCT01242748
Start Date:
October 2010
Completion Date:
January 2012
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| South Florida Medical Research | Aventura, Florida 33180 |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
| Urology San Antonio Research, PA | San Antonio, Texas 78229 |
| Seattle Urology Research Center | Burien, Washington |
| The Urology Center of Colorado | Denver, Colorado 80211 |
| Urology Associates of Dover, PA | Dover, Delaware |
| Urology Group of New Mexico, PC | Albuquerque, New Mexico |
| University of Colorado School of Medicine | Aurora, Colorado |
