Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

18 and over

Pharmaceutical / Industry

FE 200486 CS18
NCT00468286

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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.

ECOG score of ≤2.

Screening PSA level ≥ ng/mL.

Primary endpoint:

Probability of testosterone at castration level (≤05., ng/mL) from Day 28 through Day 364.

Secondary endpoints:

Probability of testosterone at castration level (≤05. ng/mL) from Day 56 through Day 364.

Serum levels of testosterone, PSA, LH, and FSH 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, electrocardiograms (ECGs), vital signs, and body weight.

Life expectancy of at least one year.

Trial Contact Information

Trial Lead Organizations/Sponsors

Ferring Pharmaceuticals, Incorporated

Weiying Gong, MD & MS

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00468286
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.