Open-Label, Randomised Parallel-Group Study

March 17, 2011 updated by: Ferring Pharmaceuticals

The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.

An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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 Criteria:

  • Patients, aged 18 years or older, with a 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.
  • Screening PSA level of =2 ng/mL. ECOG score of =2.
  • Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

  • Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

  • Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
  • Serum levels of testosterone, LH, FSH, and PSA over time.
  • Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
  • Plasma levels of degarelix over time.
  • Frequency and severity of adverse events.
  • Clinically significant changes in laboratory safety parameters.
  • Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

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: 1
  • Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
  • Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
Drug: Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
Experimental: 2
  • Starting dose of 240 mg (40 mg/mL) will be given on Day 0.
  • Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
Drug: Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
Time Frame: 3-month
3-month

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
Time Frame: 3-month
3-month
To evaluate pharmacokinetic response.
Time Frame: 3-month
3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
Time Frame: 3-month
3-month

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 Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2011

Last Update Submitted That Met QC Criteria

March 17, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS26
  • 2007-006055-39

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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