Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) 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.