An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Main
Inclusion Criteria:
- Patients, aged 18 years or over, with histologically proven prostate cancer of all
stages in whom endocrine treatment is indicated.
- Baseline testosterone >1.5 ng/mL.
- Life expectancy of at least 12 months.
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:
Percentage of Patients With Testosterone <=0.5ng/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. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
Outcome Time Frame:
12 months
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 CS21
NCT ID:
NCT00295750
Start Date:
February 2006
Completion Date:
October 2007
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Colorado | Denver, Colorado 80217 |
| Advanced Urology Medical Center | Anaheim, California 92801 |
| Urology San Antonio Research | San Antonio, Texas 78229 |
| South Florida Medical Research | Aventura, Florida 33180 |
| Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
| 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 |
| Lawrenceville Urology | Lawrenceville, New Jersey 08648 |
| University Urological Research Institute | Providence, Rhode Island 02904 |
| Pacific Clinical Center | Encino, California 91316 |
| Western Clinical Research | Torrance, California 90505 |
| Northeast Urology Research | Concord, North Carolina 28025 |
| State College Urologic Association | State College, Pennsylvania 16801 |
| Urology Associate PC | Denver, Colorado 80210 |
| Univeristy Urological Research Institute | Providence, Rhode Island 02904 |
| Office of Jeffrey Frankel | Seattle, Washington 98166 |
| Simi-San Faernando Valley Urology Associates | Granada Hills, California 91344 |
| Jay A. Motola, MD, FACS | Carmel, New York 10512 |
| Urology of Virginia Research | Norfolk, Virginia 23502 |
