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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 DEPOTĀ® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 DEPOTĀ® 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