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

• Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
• Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
  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 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.
• Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen [ Time Frame: Six months ] [ Designated as safety issue: No ]
  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.
• Number of Participants With Normal Prostate-specific Antigen Levels During the Study [ Time Frame: Weeks 12, 24 ] [ Designated as safety issue: No ]
  The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).
• The Number of Participants With Abnormal Liver Function Tests [ Time Frame: Six months ] [ Designated as safety issue: No ]
  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.
• Percentage Change in Vital Signs and Body Weight [ Time Frame: Baseline and Six months ] [ Designated as safety issue: No ]
  Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.

• Proportion of patients with testosterone < 0.5 ng/ml at all visits. [ Time Frame: Six months ] [ Designated as safety issue: No ]
• Reduction of prostate specific antigen (PSA) compared to the value at the beginning of the trial. [ Time Frame: Six months ] [ Designated as safety issue: No ]
• Evaluate the time course of testosterone, 5-α-dihydrotestosterone (DTH), luteinizing hormone (LH), follicle stimulating hormone (FSH) and PSA. [ Time Frame: Six months ] [ Designated as safety issue: No ]
• Investigate the population pharmacokinetic and pharmacodynamic profile for testosterone and DTH. [ Time Frame: Six months ] [ Designated as safety issue: No ]
• Evaluate the three dosing regimens with respect to safety and tolerability. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
• Estimate the proportion of patients meeting the withdrawal criteria for trial therapy with respect to testosterone and PSA. [ Time Frame: Six months ] [ Designated as safety issue: No ]

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.

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.

• Experimental: Degarelix 80/80 + 40
  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.
  Intervention: Drug: Degarelix
• Experimental: Degarelix 40/40 + 40
  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.
  Intervention: Drug: Degarelix
• Experimental: Degarelix 80 + 20
  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.
  Intervention: Drug: Degarelix

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