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

Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819247
• Other study ID #: FE200486 CS02
• Status: Completed
• Phase: Phase 2
• Start date: March 2001
• Est. completion date: August 2002

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2002
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Given as a subcutaneous injection.

Locations

Country	Name	City	State
United Kingdom	Ayr Hospital	Ayr
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Southmead Hospital	Bristol
United Kingdom	St. Richards Hospital	Chichester
United Kingdom	Glan Clwyd Hospital	Denbighshire
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	St. Bartholemews Hospital	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Stirling Royal Infirmary	Stirling
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Pindersfields General Hospital	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Testosterone <0.5 Nanogram/Milliliter		Weeks 1,2,4,8,12,16,20,24
Secondary	Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24		Weeks 4-24
Secondary	Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between 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.	Weeks 4-24
Secondary	Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen	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.	Six months
Secondary	Number of Participants With Normal Prostate-specific Antigen Levels During the Study	The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).	Weeks 12, 24
Secondary	The Number of Participants With Abnormal Liver Function Tests	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.	Six months
Secondary	Percentage Change in Vital Signs and Body Weight	Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.	Baseline and Six months