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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
Outcome Description:
Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
FE200486 CS18
NCT ID:
NCT00468286
Start Date:
May 2007
Completion Date:
August 2008
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| South Florida Medical Research | Aventura, Florida 33180 |
| Florida Foundation for Healthcare Research | Ocala, Florida 34474 |
| Grand Strand Urology | Myrtle Beach, South Carolina 29572 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Regional Urology | Shreveport, Louisiana 71106 |
| The Urology Center | Greensboro,, North Carolina 27401 |
| South Orange County Medical Research Center | Laguna Hills, California 92653 |
| State College Urologic Association | State College, Pennsylvania 16801 |
| Urology of Virginia Research | Norfolk, Virginia 23502 |
| Investigational Site | New York, New York 10032 |
| Urology Research Center | Seattle, Washington 98166 |
