 - Previous or present hormonal management of prostate cancer surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens. However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit. 