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, 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
1 other identifier
interventional
133
5 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started May 2007
Shorter than P25 for phase_2 prostate-cancer
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
March 3, 2011
CompletedMarch 23, 2011
March 1, 2011
1.3 years
April 13, 2007
February 8, 2011
March 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.
1 year
Secondary Outcomes (8)
Serum Levels of Testosterone Over Time
1 year
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364
1 year
Probability of no PSA Failure
1 year
Serum Levels of PSA Over Time
1 year
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
1 year
- +3 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALTreatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
B
EXPERIMENTALTreatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Interventions
Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Investigational site
Carmel, New York, 10512, United States
The Urology Center
Greensboro, North Carolina, 27403, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Urology of Virginia Research
Norfolk, Virginia, 23502, United States
Urology Research Center
Seattle, Washington, 98166, United States
Investigational site
Surrey, British Columbia, Canada
Investigational site
Victoria, British Columbia, Canada
Investigational site
Kentville, Nova Scotia, Canada
The Female/Male Health Centres
Ontario, Canada
Nemocnice Jindrichuv Hradec a.s.
Hradec, Czechia
Slezska nemocnice
Opava, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Dombóvári Szent Lukács Egészségügyi Kht
Dombóvár, Hungary
Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
Miskolc, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Private Medical Center
Arad, Romania
"Prof Dr Th Burghele" Clinical Hospital
Bucharest, Romania
Dinu Uromedica
Bucharest, Romania
Fundeni Clinical Institute
Bucharest, Romania
E-Uro Medical Center S.R.L.
Cluj-Napoca, Romania
Provita Center
Constanța, Romania
Sibiu County Clinical Hospital
Sibiu, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 13, 2007
First Posted
May 2, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 23, 2011
Results First Posted
March 3, 2011
Record last verified: 2011-03