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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Degarelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix 80/80 + 40<br>Loading 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. | Drug: Degarelix<br>* Given as a subcutaneous injection.<br>* Other names: FE 200486;|
| Experimental: Degarelix 40/40 + 40<br>Loading 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. | Drug: Degarelix<br>* Given as a subcutaneous injection.<br>* Other names: FE 200486;|
| Experimental: Degarelix 80 + 20<br>Loading 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. | Drug: Degarelix<br>* Given as a subcutaneous injection.<br>* Other names: FE 200486;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Testosterone <0.5 Nanogram/Milliliter |  | Weeks 1,2,4,8,12,16,20,24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |