At a glance
ClinicalIndex Comparison Record- ✓Male patient with histologically proven adenocarcinoma of the prostate (all stages) with indication for endocrine treatment, excluding neoadjuvant hormonal therapy; PSA increases on two consecutive determinations ≥2 weeks apart prior to Visit 1.
- ✓Age ≥18 years.
- ✓ECOG performance status 0–2.
- ✓Baseline testosterone level within age-specific normal range (central laboratory measurement).
- ✕Previous or present hormonal management for prostate cancer (surgical castration, GnRH agonists, GnRH antagonists, antiandrogens, estrogens), except neoadjuvant hormonal therapy <6 months duration completed >6 months prior to Visit 1.
- ✕Requires hormonal therapy for neoadjuvant purposes.
- ✕Recent (within 12 weeks prior to Visit 1) or current treatment with drugs modifying testosterone level or function.
- ✕Candidate for curative therapy (radical prostatectomy or radiotherapy) within 6 months after Visit 1.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
In Brief
A Phase 2 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 82 participants across 12 sites.
Detailed Summary
Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.
Study Details
Timeline
Interventions
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.