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
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
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
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:
- No previous hormonal treatment for prostate cancer
- Considered to be candidate for curative therapy
- No 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Outcome Time Frame:
Day 28 to Day 364
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
China: Food and Drug Administration
Study ID:
000006
NCT ID:
NCT01744366
Start Date:
January 2013
Completion Date:
April 2015
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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