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 Withdrawn/discontinued from FE200486 CS21 study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>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of degarelix in suppressing androgen production for prostate cancer?
How does the one-month dosing regimen of degarelix compare to standard androgen ablation therapies in efficacy and safety?
What biomarkers correlate with long-term tolerability of degarelix in prostate cancer patients undergoing androgen deprivation therapy?
What are the most common adverse events reported in degarelix trials and how are they managed in clinical practice?
Are there any combination therapies involving degarelix and other GnRH antagonists being explored for advanced prostate cancer treatment?