The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

December 17, 2012 updated by: Ferring Pharmaceuticals

An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

The study was a three-arm, active-control, multi-centre, parallel group study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

620

Phase

  • Phase 3

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
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4KB
        • Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
  • Czech Republic
      • Jindrichuv Hradec, Czech Republic, 37738
        • Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
  • Germany
      • Mannheim, Germany, 68167
        • Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
  • Hungary
      • Szeged, Hungary, H-6725
        • Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
  • Mexico
    • Durango, DGO
      • Predio Canoas S/N, Durango, DGO, Mexico, 34079
        • Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
  • Netherlands
      • Heerlen, Netherlands, 6419 PC
        • Atrium MC, Henri Dunantstraat 5
  • Puerto Rico
      • La Hacienda, Puerto Rico, 00784
        • Cristo Redentor Hospital
      • San Juan, Puerto Rico, 00921
        • San Juan VA Medical Center
  • Romania
      • Constanta, Romania, 900635
        • Provita Center, 2 Primaverii Street
  • Russian Federation
      • St Petersburg, Russian Federation, 197136
        • Andros Urology Clinic, Ulitsa Lenina 36A
  • Ukraine
      • Kiev, Ukraine, 2125
        • Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
  • United Kingdom
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital, Derriford Road
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center, LLC
    • California
      • Anaheim, California, United States, 92801
        • Advanced Urology Medical Center
      • Beverly Hills, California, United States, 90210
        • Pacific Clinical Center
      • Granada Hills, California, United States, 91344
        • Simi-San Faernando Valley Urology Associates
      • Laguna Woods,, California, United States, 92653
        • South Orange County Medical Research Center
      • Torrance, California, United States, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80210
        • Urology Associate PC
      • Denver, Colorado, United States, 80262
        • University of Colorado
    • 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 Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology
    • New York
      • Carmel, New York, United States, 10512
        • Jay A. Motola, MD, FACS
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Northeast Urology Research
      • Greensboro, North Carolina, United States, 27401
        • The Urology Center
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • State College Urologic Association
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Univeristy Urological Research Institute
      • Providence, Rhode Island, United States, 02904
        • University Urological Research Institute
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Urology
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Urology of Virginia Research
    • Washington
      • Seattle, Washington, United States, 98166
        • Office of Jeffrey Frankel

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

Main Inclusion Criteria:

  • Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Baseline testosterone >1.5 ng/mL.
  • Life expectancy of at least 12 months.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: degarelix 240/160 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
Drug: Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
Other Names:
  • FE200486
Drug: Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Other Names:
  • FE 200486
Experimental: degarelix 240/80 mg
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
Drug: Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
Other Names:
  • FE200486
Drug: Degarelix
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Other Names:
  • FE 200486
Active Comparator: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Drug: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Other Names:
  • Lupron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Time Frame: 12 months
Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
Time Frame: 2 weeks
A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
Time Frame: 3 days
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
3 days
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Time Frame: Day 252, Day 255, and Day 259
Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.
Day 252, Day 255, and Day 259
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Time Frame: Days 14 and 28
Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.
Days 14 and 28
Participants Grouped by Time to Prostate-specific Antigen Failure
Time Frame: 12 months
The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
12 months
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
Time Frame: Baseline to Day 364
Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.
Baseline to Day 364
The Mean Value of QTc Interval as Measured by Electrocardiogram
Time Frame: 12 months
The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.
12 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time Frame: 12 months
Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
12 months

Collaborators and Investigators

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

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS21

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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