The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
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
1 other identifier
interventional
129
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Mar 2001
Shorter than P25 for phase_2 prostate-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 7, 2009
CompletedFirst Posted
Study publicly available on registry
January 8, 2009
CompletedResults Posted
Study results publicly available
March 31, 2009
CompletedNovember 9, 2023
May 1, 2011
1.2 years
January 7, 2009
January 22, 2009
November 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Weeks 1,2,4,8,12,16,20,24
Secondary Outcomes (6)
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Weeks 4-24
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Six months
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Weeks 12, 24
The Number of Participants With Abnormal Liver Function Tests
Six months
- +1 more secondary outcomes
Study Arms (3)
Degarelix 80/80 + 40
EXPERIMENTALLoading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40
EXPERIMENTALLoading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20
EXPERIMENTALLoading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.
Interventions
Given as a subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 7, 2009
First Posted
January 8, 2009
Study Start
March 1, 2001
Primary Completion
May 1, 2002
Study Completion
August 1, 2002
Last Updated
November 9, 2023
Results First Posted
March 31, 2009
Record last verified: 2011-05