Male age 18 years or older, with histologically proven prostate cancer of all stages, for whom endocrine treatment is not indicated
Life expectancy of at least 12 months
No hormone therapy prior to study entrance
Cannot be at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
Cannot have a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
Cannot have a history or presence of any other malignancy other than treated squamous cell/ basal cell carcinoma of the skin within the last five years
Cannot have any 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