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
Phase 3
Completed
- Conditions
- prostate cancer10038364
- Registration Number
- NL-OMON31249
- Lead Sponsor
- Ferring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
1. Written informed consent
2. Completion of FE200486 CS21 study
Exclusion Criteria
1. Withdrawn/discontinued from FE200486 CS21 study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>•Changes in clinical safety parameters (adverse events including death from any<br /><br>cause, physical examinations, electrocardiograms (ECGs), vital signs, and body<br /><br>weight)<br /><br>•Clinically significant changes in laboratory safety parameters (clinical<br /><br>chemistry, haematology, and urinalysis)</p><br>
- Secondary Outcome Measures
Name Time Method <p>•Proportion of patients with testosterone level maintained at <=0.5 ng/mL from<br /><br>start of FE 200486 CS21A and onwards<br /><br>•Proportion of patients treated with degarelix with testosterone level<br /><br>maintained at <=0.5 ng/mL from Day 28 in FE 200486 CS21 and onwards<br /><br>•Proportion of patients switching from LUPRON DEPOT® 7.5 mg to degarelix with<br /><br>testosterone level maintained below 0.5 ng/mL from Day 28 in FE 200486 CS21A<br /><br>and onwards<br /><br>•Time to testosterone level above 0.5 ng/mL<br /><br>•Serum levels of testosterone and PSA over time<br /><br>•Time to PSA progression - defined as two consecutive increases of 50%, and at<br /><br>least 5 ng/mL, compared to nadir (obtained in either FE 200486 CS21 or FE<br /><br>200486 CS21A)<br /><br>•Serum levels of testosterone, PSA, LH, and FSH from the time of switch from<br /><br>LUPRON DEPOT® to degarelix</p><br>