Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

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.

Inclusion Criteria:

• Written informed consent obtained before any trial related procedures
• Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
• ECOG score to be equal to or above 2
• Testosterone level within age-specific normal range
• PSA value equal to or above 2 ng/ml
• Life expectancy of at least 6 months

Exclusion Criteria:

• Previous or current hormonal treatment of prostate cancer
• Recent or current treatment with any drugs modifying the testosterone level
• Candidate for curative treatment such as 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
• Signs of liver impairment shown as elevated serum ALT or serum bilirubin
• Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
• 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