At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate (all stages) requiring endocrine treatment, including patients with rising PSA after prostatectomy or radiotherapy
- ✓Male aged ≥18 years
- ✓Baseline serum testosterone >2.2 ng/mL
- ✓ECOG performance status of 0-2
- ✕Prior or current hormonal therapy for prostate cancer (surgical castration, GnRH agonists/antagonists, antiandrogens, estrogens); exception: neoadjuvant therapy ≤6 months must have ended ≥6 months before screening
- ✕Candidate for curative therapy (radical prostatectomy or radiotherapy) within 13 months
- ✕History of or predisposition to severe hypersensitivity reactions (severe asthma requiring daily inhaled steroids, anaphylaxis, chronic/recurrent urticaria and/or angioedema)
- ✕Hypersensitivity to any component of degarelix
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 460 participants across 56 sites in 11 countries.
Detailed Summary
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.
Study Details
Timeline
Interventions
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9
Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10