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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
Not Enrolling
Male
Prostate Cancer

Thank you

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- Has been withdrawn from the CS35 trial.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 ResearchAventura, Florida  33180
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Urology San Antonio Research, PASan Antonio, Texas  78229
Seattle Urology Research CenterBurien, Washington  
The Urology Center of ColoradoDenver, Colorado  80211
Urology Associates of Dover, PADover, Delaware  
Urology Group of New Mexico, PCAlbuquerque, New Mexico  
University of Colorado School of MedicineAurora, Colorado