The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer

The proposed clinical trial will study the effects of 12 months of therapy with ARN-509
alone, or in combination with an LHRH agonist (LHRHa), each compared with LHRHa alone, in men
with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The
endpoints selected reflect measurable short term effects of androgen deprivation therapy
(ADT), including quality of life and several metabolic parameters. In addition, the relative
effect of each treatment strategy on PSA suppression as well as testosterone recovery (and
subsequent PSA progression) after 12 months of therapy will be evaluated.