An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy
- Conditions
- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer
- Registration Number
- EUCTR2006-006913-34-DE
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 568
Inclusion Criteria
• Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated
• Signed informed consent
• The patients must have completed the FE 200486 CS21 study
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
• Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated
• Signed informed consent
• The patients must have completed the FE 200486 CS21 study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•To evaluate PSA response during long-term treatment with degarelix one-month dosing regimen<br>•To evaluate testosterone, PSA, LH, and FSH responses from the time of switch from LUPRON DEPOT® to degarelix<br>;Primary end point(s): • Changes in clinical safety parameters (adverse events including death from any cause, physical examinations, electrocardiograms (ECGs), vital signs, and body weight)<br>• Clinically significant changes in laboratory safety parameters (clinical chemistry, haematology, and urinalysis)<br>
- Secondary Outcome Measures
Name Time Method