NCT01744366
Completed
Phase 3
An Open-label, Multi-centre, Randomised, Parallel-group Trial, Comparing Efficacy and Safety of Degarelix One-month Dosing Regimen With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Overview
- Phase
- Phase 3
- Intervention
- Degarelix
- Conditions
- Prostate Cancer
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 285
- Locations
- 29
- Primary Endpoint
- Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
One month degarelix/comparator treatment for prostate cancer in Chinese population
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chinese male over 18 years
- •Adenocarcinoma of the prostate
- •Relevant disease status based on lab values and as judged by the physician
- •Life expectancy of at least a year
Exclusion Criteria
- •Previous hormonal treatment for prostate cancer
- •Considered to be candidate for curative therapy
- •Risk or history of any serious or significant health condition
- •Has received an investigational drug within the last 28 days and no previous treatment with degarelix
Arms & Interventions
Degarelix
Degarelix 240/80 mg
Intervention: Degarelix
Goserelin
Goserelin 3.6 mg
Intervention: Goserelin
Outcomes
Primary Outcomes
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Time Frame: Day 28 to Day 364
Secondary Outcomes
- Proportion of patients with testosterone levels ≤0.5 ng/mL(at Day 3)
- Percentage change in prostate-specific antigen (PSA)(from baseline to Day 28)
- Changes in testosterone and PSA levels(Day 0 to 364)
- Significant changes in laboratory values(Day 0 to Day 364)
- Significant changes in vital signs(Day 0 to Day 364)
- Significant changes in body weight(Day 0 to Day 364)
- Frequency and severity of adverse events(Day 0 to Day 364)
- Cumulative probability of no PSA failure(Day 0 to Day 364)
Study Sites (29)
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