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

March 21, 2011 updated by: Ferring Pharmaceuticals

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

Intervention / 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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Všeobecná fakultní 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year
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
Time Frame: 1 year
1 year
Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364
Time Frame: 1 year
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
Time Frame: 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).
1 year
Serum Levels of PSA Over Time
Time Frame: 1 year
1 year
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
Time Frame: 1 year
1 year
Serum Levels of Luteinizing Hormone (LH) Over Time
Time Frame: 1 year
1 year
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time Frame: 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.
Baseline up to 1 year
Liver Function Tests
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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