An Open-Label, Multi-Centre, Extension Study, evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens, 240 mg (40 mg/mL), 240 mg (60 mg/mL), in Patients with Prostate Cancer. -
Phase 1
Active, not recruiting
- Conditions
- Prostate cancer patientMedDRA version: 7.0Level: pr tClassification code 10060862
- Registration Number
- EUCTR2005-004943-72-BE
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- 425
Inclusion Criteria
Has completed the CS15 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
Has been withdrawn from the FE200486 CS15 study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 the safety and tolerability of different dosing regimens;Primary end point(s): Changes in clinical safety parameters (adverse events including death from any cause, local tolerability, physical examination, vital signs, ECG and body weight)<br>Clinically significant changes in laboratory safety parameters (biochemistry and haematology) <br>;Secondary Objective: To evaluate the proportion of patients with testosterone =0.5 ng/mL of different dosing regimens. <br>To evaluate the proportion of patients with disease progression (PSA progression, death from any cause, introduction of additional therapy-related to the prostate cancer) of different dosing regimens.<br>
- Secondary Outcome Measures
Name Time Method
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 molecular mechanisms underlie Degarelix's GnRH receptor antagonism in prostate cancer management?
How do 240 mg (40 mg/mL) and 60 mg/mL Degarelix dosing regimens compare to standard-of-care GnRH antagonists in long-term prostate cancer trials?
Which biomarkers correlate with improved safety or tolerability outcomes in Degarelix-treated prostate cancer patients from EUCTR2005-004943-72-BE?
What long-term adverse events are associated with 3-month Degarelix dosing in prostate cancer, and how are they managed clinically?
How does Degarelix's safety profile in Phase I prostate cancer trials compare to competitor drugs like Abarelix or Cetrorelix in androgen deprivation therapy?