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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 ColoradoDenver, Colorado  80217
Advanced Urology Medical CenterAnaheim, California  92801
Urology San Antonio ResearchSan Antonio, Texas  78229
South Florida Medical ResearchAventura, Florida  33180
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Grand Strand UrologyMyrtle Beach, South Carolina  29572
Urology Centers Of AlabamaHomewood,, Alabama  35205
Regional UrologyShreveport, Louisiana  71106
The Urology CenterGreensboro,, North Carolina  27401
South Orange County Medical Research CenterLaguna Hills, California  92653
Lawrenceville UrologyLawrenceville, New Jersey  08648
University Urological Research InstituteProvidence, Rhode Island  02904
Pacific Clinical CenterEncino, California  91316
Western Clinical ResearchTorrance, California  90505
Northeast Urology ResearchConcord, North Carolina  28025
State College Urologic AssociationState College, Pennsylvania  16801
Urology Associate PCDenver, Colorado  80210
Univeristy Urological Research InstituteProvidence, Rhode Island  02904
Office of Jeffrey FrankelSeattle, Washington  98166
Simi-San Faernando Valley Urology AssociatesGranada Hills, California  91344
Jay A. Motola, MD, FACSCarmel, New York  10512
Urology of Virginia ResearchNorfolk, Virginia  23502