Prostate cancer MedDRA version: 12.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Degarelix
Product Code: FE200486
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Degarelix
CAS Number: 214766-78-6
Concentration unit: mg millig
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Each patient must meet the following inclusion criteria before entry into the trial: 1. 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. 2. Has completed the CS35 trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any patient meeting the following exclusion criteria will not be entered into the trial: 1. Has been withdrawn from the CS35 trial. 2. Has had EOT visit in CS35 prior to approval of the CS35A protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as either PSA failure or death, whichever is first);Secondary Objective: •To compare PFS failure rates (PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer, or death, whichever is first) •To compare disease progression in terms of PSA failure rates •To compare disease progression in terms of rates of introduction of additional therapy related to prostate cancer •To compare the disease progression in terms of mortality rates •To evaluate testosterone and PSA responses to degarelix or goserelin treatment •To compare testosterone response in terms of testosterone escape (defined as serum levels >0.5 ng/mL) rates •To compare safety and tolerability profiles of the two drugs during long-term treatment;Primary end point(s): Hazard ratio of PSA PFS failure rates during 3 years treatment between degarelix and goserelin | — |
Countries
Czech Republic, Finland, Germany, Hungary, Netherlands, United Kingdom
Outcome results
None listed