Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Has given written informed consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient 2.Has completed the one-year main study, FE 200486 CS21 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Exclusion criteria: 1.Has been withdrawn/discontinued from the FE 200486 CS21 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients;Secondary Objective: •To evaluate testosterone response during long-term treatment with degarelix one-month dosing regimen •To evaluate PSA response during long-term treatment with degarelix one-month dosing regimen •To evaluate testosterone, PSA, LH, and FSH responses from the time of switch from LUPRON DEPOT® to degarelix ;Primary end point(s): •Changes in clinical safety parameters (adverse events including death from any cause, physical examination, vital signs, ECGs, and body weight) •Clinically significant changes in laboratory safety parameters (clinical chemistry, haematology, and urinalysis) | — |
Countries
Czech Republic, Germany, Hungary, Netherlands, United Kingdom
Outcome results
None listed