Skip to main content
OpenTrials
Completed

NCT Number: NCT00819247

The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ayr Hospital, Ayr, United Kingdom

Loading trial locations.

About this study

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent before any trial related activity
  • Proven prostate cancer with a need for endocrine treatment
  • Testosterone level within the normal range for the age

Exclusion criteria

  • Previous or current hormonal treatment of prostate cancer
  • Candidate for prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions or Quincke's Oedema
  • Hypersensitivity towards any component of FE200486
  • Cancer disease within the last ten years except for prostate cancer and some skin cancers
  • Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial

Treatment and study plan

degarelix

Drug

Given as a subcutaneous injection.

Other names: FE 200486

Primary outcomes

  1. Number of Participants With Testosterone <0.5 Nanogram/Milliliter

    Time frame: Weeks 1,2,4,8,12,16,20,24

Secondary outcomes

  1. Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24

    Time frame: Weeks 4-24

  2. Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24

    Time frame: Weeks 4-24

    Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.

  3. Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen

    Time frame: Six months

    Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.

  4. Number of Participants With Normal Prostate-specific Antigen Levels During the Study

    Time frame: Weeks 12, 24

    The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).

  5. The Number of Participants With Abnormal Liver Function Tests

    Time frame: Six months

    The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.

  6. Percentage Change in Vital Signs and Body Weight

    Time frame: Baseline and Six months

    Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 8, 2009
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.