PRIMARY OBJECTIVE:~I. To determine the effects of low dose apalutamide on circulating levels of prostate specific antigen (PSA).~SECONDARY OBJECTIVES:~I. To determine the effect of low dose apalutamide on:~Ia. Reversibility of testosterone levels 7-14 days post intervention; Ib. Post-intervention plasma trough apalutamide concentration; Ic. Health-related quality of life.~EXPLORATORY OBJECTIVE:~I. To determine the effects of apalutamide on intra-prostatic immune cell infiltration and Gleason score as exploratory endpoints.~OUTLINE:~Patients receive apalutamide orally (PO) on study. Patients also undergo collection of blood samples throughout the study.
This phase IIa trial investigates the biomarker (plasma levels of PSA) of low-dose apalutamide in patients with prostate cancer confined in the prostate gland before surgery. Testosterone can cause the growth of prostate cancer cells, and Apalutamide blocks the use of testosterone by the tumor cells. Giving low-dose apalutamide before prostate surgery may lead to lowered PSA levels in men with prostate cancer confined to the prostate gland.