• 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 ]
• Number of Participants Who Met the Withdrawl Criteria for Prostate-Specific Antigen [ Time Frame: Six months ] [ Designated as safety issue: No ]
• 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 With Abnormal Liver Function Tests [ Time Frame: Six months ] [ Designated as safety issue: No ]
• Percentage Change in Vital Signs and Body Weight [ Time Frame: Baseline and 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 ]
• Proportion of patients with testosterone < 0.5 ng/ml at all visits. [ 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 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 ]
• 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: 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.
• Experimental: 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.
• Experimental: 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.

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