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Brief Title: Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
Official Title: Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
Study ID: NCT04530552
Brief Summary: Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.
Detailed Description: 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 and the effects of tobacco/alcohol use on the study endpoints. OUTLINE: Patients receive apalutamide orally (PO) on study. Patients also undergo collection of blood samples throughout the study. After completion of the trial intervention, patients are followed up at 7-10 days, 60 days, and 3 months post-prostatectomy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of Arizona Cancer Center - Prevention Research Clinic, Tucson, Arizona, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC San Diego Medical Center - Hillcrest, San Diego, California, United States
George Washington University Medical Center, Washington, District of Columbia, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
NCI - Center for Cancer Research, Bethesda, Maryland, United States
Name: Juan Chipollini
Affiliation: University of Arizona Cancer Center - Prevention Research Clinic
Role: PRINCIPAL_INVESTIGATOR