Status:
COMPLETED
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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 An...
Eligibility Criteria
Inclusion
- Inclusion / 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 ≤2.
- Screening prostate-specific antigen (PSA) level ≥ ng/mL.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00468286
Start Date
May 1 2007
End Date
August 1 2008
Last Update
March 23 2011
Active Locations (29)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
3
South Florida Medical Research
Aventura, Florida, United States, 33180
4
Florida Foundation for Healthcare Research
Ocala, Florida, United States, 34474