Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

Exclusion Criteria

• •Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
• •Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
• •Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
• •Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
• •Known hypersensitivity towards any component of the investigational medical product.
• •History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• •Known or suspected clinically significant liver and/or biliary disease.
• •Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• •Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• •Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
• •Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
• •Previous participation in any degarelix trial.