Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00468286
• Lead Sponsor: Ferring Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2007-04-13
• Study Start: 2007-05
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2009-07-02
• Disposition First Submitted QC: 2009-10-01
• Disposition First Posted: 2009-10-02
• Results First Submitted: 2011-02-08
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-02
• Results First Posted: 2011-03-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 133

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Degarelix	Treatment 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	Degarelix	Treatment 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.

Primary Outcome Measures

Name	Time	Method
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364	1 year	Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364.

Secondary Outcome Measures

Name	Time	Method
Serum Levels of PSA Over Time	1 year
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	Baseline up to 1 year	This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
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	Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 56 to Day 364.
Probability of no PSA Failure	1 year	Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).
Serum Levels of Luteinizing Hormone (LH) Over Time	1 year
Liver Function Tests	1 year	The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time	1 year

Trial Locations

Locations (26)

Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

The Urology Center; 🇺🇸 Greensboro, North Carolina, United States

State College Urologic Association; 🇺🇸 State College, Pennsylvania, United States

Slezska nemocnice; 🇨🇿 Opava, Czech Republic

Vseobecna fakultni nemocnice v Praze; 🇨🇿 Praha, Czech Republic

Dombóvári Szent Lukács Egészségügyi Kht; 🇭🇺 Dombovar, Hungary

Dinu Uromedica; 🇷🇴 Bucharest, Romania

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Woods, California, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Investigational site; 🇨🇦 Kentville, Nova Scotia, Canada

Florida Foundation for Healthcare Research; 🇺🇸 Ocala, Florida, United States

Urology of Virginia Research; 🇺🇸 Norfolk, Virginia, United States

Grand Strand Urology; 🇺🇸 Myrtle Beach, South Carolina, United States

The Female/Male Health Centres; 🇨🇦 Ontario, Canada

Urology Research Center; 🇺🇸 Seattle, Washington, United States

Nemocnice Jindrichuv Hradec a.s.; 🇨🇿 Hradec, Czech Republic

Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház; 🇭🇺 Miskolc, Hungary

Private Medical Center; 🇷🇴 Arad, Romania

Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ; 🇭🇺 Miskolc, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; 🇭🇺 Szeged, Hungary

"Prof Dr Th Burghele" Clinical Hospital; 🇷🇴 Bucharest, Romania

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania

E-Uro Medical Center S.R.L.; 🇷🇴 Cluj-Napoca, Romania

Provita Center; 🇷🇴 Constanta, Romania

Sibiu County Clinical Hospital; 🇷🇴 Sibiu, Romania