Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

Summary

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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 pla...

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. Intra-prostatic immune cell infiltration. Id. Health-related quality of life. Ie. Gleason score of pre- and post-intervention tumor(s) with matched location. OUTLINE: The first 40 patients taking part in this trial receive apalutamide orally (PO) three times a week (TIW) for 4-8 weeks prior to before prostate surgery in the absence of disease progression or unacceptable toxicity. Based on PSA levels of the first 40 patients, the next group of 40 patients receive apalutamide either once a week (QW) or once daily (QD) for 4-8 weeks prior to before prostate surgery in the absence of disease progression or unacceptable toxicity. Patients may receive apalutamide for up to 12 weeks before prostate surgery (in the event surgery is delayed). After completion of study treatment, patients are followed up at 7-14 days after prostate surgery.

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