Patient description: The patient is a 55 year old man visiting his primary care physician for lower urinary tract symptoms including frequency, urgency, weak stream, incomplete emptying and intermittent flow for the past 9 months. Further evaluation revealed: IPSS score : 15 Post-void residual: 70 mL Prostate volume (TRUS): 60 mL Prostate-specific antigen (PSA) level: 3.2 ng/mL 10 mL/sec of maximum flow rate when urine volume was 130 mL He is otherwise healthy only using Vit D 1000 units daily. His recent blood chemistry (3 days ago) was normal: Hgb: 13.5 g/dl WBC: 135000 /mm3 Plt: 350000 /ml PT: 11 second PTT: 35 second INR: 0.9 Creatinine: 0.5 mg/dl BUN: 10 mg/dl U/A: Color: yellow Appearance: cloudy PH: 5.3 Specific gravity: 1.010 Glc: 100 Nitrite: negative Ketone: none Leukocyte esterase: negative RBC: negative WBC: 2 WBCs/hpf U/C: negative

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Prostate Cancer Has given written consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention Is a male patient aged 18 years or over Has a baseline serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL Has an ECOG (Eastern Cooperative Oncology Group) score of 2 Has a PSA value of 2 ng/mL Has a life expectancy of at least 13 months  Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to the Screening Visit Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or radiotherapy within 13 months from Screening Visit Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema Has hypersensitivity towards any component of the investigational medicinal product. 5. Has had a cancer disease within the last five years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin Has a known or suspected hepatic or symptomatic biliary disease Has elevated serum ALT level above upper level of normal range or serum total bilirubin level above upper level of normal range as measured by the laboratory at the Screening Visit Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator Has a mental incapacity or language barriers precluding adequate understanding or cooperation Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study