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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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