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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Drug: Degarelix

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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario, Canada
    • The Female/Male Health Centres
  • British Columbia
    • Surrey, British Columbia, Canada
      • Investigational Site
    • Victoria, British Columbia, Canada
      • Investigational Site
  • Nova Scotia
    • Kentville, Nova Scotia, Canada
      • Investigational Site
• Czech Republic
  • Hradec, Czech Republic
    • Nemocnice Jindrichuv Hradec a.s.
  • Opava, Czech Republic
    • Slezská nemocnice
  • Praha, Czech Republic
    • Vseobecna fakultni nemocnice v Praze
• Hungary
  • Dombovar, Hungary
    • Dombóvári Szent Lukács Egészségügyi Kht
  • Miskolc, Hungary
    • Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház
  • Miskolc, Hungary
    • Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ
  • Szeged, Hungary
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Romania
  • Arad, Romania
    • Private Medical Center
  • Bucharest, Romania
    • Dinu Uromedica
  • Bucharest, Romania
    • Fundeni Clinical Institute
  • Bucharest, Romania
    • "Prof Dr Th Burghele" Clinical Hospital
  • Cluj-Napoca, Romania
    • E-Uro Medical Center S.R.L.
  • Constanta, Romania
    • Provita Center
  • Sibiu, Romania
    • Sibiu County Clinical Hospital
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers Of Alabama
  • California
    • Laguna Woods, California, United States, 92653
      • South Orange County Medical Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Ocala, Florida, United States, 34474
      • Florida Foundation for Healthcare Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • New York
    • Carmel, New York, United States, 10512
      • Investigational Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • The Urology Center
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • State College Urologic Association
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Urology
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Urology of Virginia Research
  • Washington
    • Seattle, Washington, United States, 98166
      • Urology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; 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.	Drug: Degarelix; 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.; Drug: Degarelix; Experimental 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.
EXPERIMENTAL: B; 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.	Drug: Degarelix; 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.; Drug: Degarelix; Experimental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Levels of Testosterone Over Time		1 year
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364	Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.	1 year
Probability of no PSA Failure	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).	1 year
Serum Levels of PSA Over Time		1 year
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time		1 year
Serum Levels of Luteinizing Hormone (LH) Over Time		1 year
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	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.	Baseline up to 1 year
Liver Function Tests	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.	1 year

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: April 13, 2007
• First Submitted That Met QC Criteria: May 1, 2007
• First Posted (ESTIMATE): May 2, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 21, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FE200486 CS18