An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 133
- Locations
- 26
- Primary Endpoint
- Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
Study Overview
Brief Summary
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
Detailed Description
An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- •Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
- •Eastern Cooperative Oncology Group (ECOG) score of ≤
- •Screening prostate-specific antigen (PSA) level ≥ ng/mL.
Arms & Interventions
A
Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
Intervention: Degarelix (Drug)
B
Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
Intervention: Degarelix (Drug)
Outcomes
Primary Outcomes
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
Time Frame: 1 year
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
Secondary Outcomes
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight(Baseline up to 1 year)
- Serum Levels of Testosterone Over Time(1 year)
- Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364(1 year)
- Serum Levels of PSA Over Time(1 year)
- Probability of no PSA Failure(1 year)
- Serum Levels of Luteinizing Hormone (LH) Over Time(1 year)
- Liver Function Tests(1 year)
- Serum Levels of Follicle Stimulating Hormone (FSH) Over Time(1 year)