Histologically confirmed (Gleason graded) adenocarcinoma of the prostate (non-metastatic)
Men 18 years of age or older
A life expectancy of at least fifteen months
Documented absence of visceral or bony metastasis evidenced by CT scan, MRI scan, or bone scan within the last six months
No adjuvant hormone therapy twelve months prior to randomization
No history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
No 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
No 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
Not part of an ongoing clinical trial
Duration of Study Study period will be approximately 14 months.
