Clinical trial NCT00468286: Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-02
Enrollment: 133
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
timeFrame: 1 year
Secondary outcomes:
measure: Serum Levels of Testosterone Over Time
timeFrame: 1 year
measure: Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364
timeFrame: 1 year
measure: Probability of no PSA Failure
timeFrame: 1 year
measure: Serum Levels of PSA Over Time
timeFrame: 1 year
measure: Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
timeFrame: 1 year
measure: Serum Levels of Luteinizing Hormone (LH) Over Time
timeFrame: 1 year
measure: Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
timeFrame: Baseline up to 1 year
measure: Liver Function Tests
timeFrame: 1 year
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Laguna Woods
country: United States
facility: South Orange County Medical Research Center
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Carmel
country: United States
facility: Investigational site
state: New York
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Norfolk
country: United States
facility: Urology of Virginia Research
state: Virginia
city: Seattle
country: United States
facility: Urology Research Center
state: Washington
city: Surrey
country: Canada
facility: Investigational site
state: British Columbia
city: Victoria
country: Canada
facility: Investigational site
state: British Columbia
city: Kentville
country: Canada
facility: Investigational site
state: Nova Scotia
city: Ontario
country: Canada
facility: The Female/Male Health Centres
city: Hradec
country: Czech Republic
facility: Nemocnice Jindrichuv Hradec a.s.
city: Opava
country: Czech Republic
facility: Slezska nemocnice
city: Praha
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Dombovar
country: Hungary
facility: Dombóvári Szent Lukács Egészségügyi Kht
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
city: Miskolc
country: Hungary
facility: Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
city: Arad
country: Romania
facility: Private Medical Center
city: Bucharest
country: Romania
facility: "Prof Dr Th Burghele" Clinical Hospital
city: Bucharest
country: Romania
facility: Dinu Uromedica
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Cluj-Napoca
country: Romania
facility: E-Uro Medical Center S.R.L.
city: Constanta
country: Romania
facility: Provita Center
city: Sibiu
country: Romania
facility: Sibiu County Clinical Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: