International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer

Inclusion Criteria:

Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
Screening testosterone > 1.5 ng/ml
Life expectancy of at least 12 months
ECOG score of ≤ 2
Patient has reviewed and signed Informed consent form
Patient understands and is willing to comply with the protocol

Exclusion Criteria:

Any hormone therapy prior to study entrance
Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
History of hypersensitivity towards any components of the study drug
History or presence of any other malignancy other than treated squamous cell /basal cell carcinoma of the skin within the last five years
ECG at screening showing QTc >450 ms, or family history of long QT syndrome

Abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial

• - Has a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator

Taking Class IA or Class III antiarrhythmic medication
Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
Has received investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of this trial
Has previously participated in any Ozarelix trials
Is part of an ongoing trial.