Clinical trial NCT00819247: The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 129
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Testosterone <0.5 Nanogram/Milliliter
timeFrame: Weeks 1,2,4,8,12,16,20,24
Secondary outcomes:
measure: Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
timeFrame: Weeks 4-24
measure: Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
timeFrame: Weeks 4-24
measure: Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
timeFrame: Six months
measure: Number of Participants With Normal Prostate-specific Antigen Levels During the Study
timeFrame: Weeks 12, 24
measure: The Number of Participants With Abnormal Liver Function Tests
timeFrame: Six months
measure: Percentage Change in Vital Signs and Body Weight
timeFrame: Baseline and Six months
Other outcomes:
Locations:
city: Ayr
country: United Kingdom
facility: Ayr Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Chichester
country: United Kingdom
facility: St. Richards Hospital
city: Denbighshire
country: United Kingdom
facility: Glan Clwyd Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St. Bartholemews Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Stirling
country: United Kingdom
facility: Stirling Royal Infirmary
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Wakefield
country: United Kingdom
facility: Pindersfields General Hospital
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: