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.
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 and at 60 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
34
Given PO
Undergo collection of blood samples
Ancillary studies
University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
George Washington University Medical Center
Washington D.C., 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
Change in Prostate Specific Antigen (PSA) Levels
The proportion of participants with \>= 25% decline in PSA levels (from baseline to end-of-intervention) will be reported along with the 97.5% credible interval for the response rate based on the posterior distribution of the response rate derived from a non-informative prior for the response rate, which is consistent with the Bayesian approach.
Time frame: Baseline to end-of-intervention (mean 4.8 weeks; up to 9 weeks)
Reversibility of Testosterone Levels
Mean change in testosterone from end-of-intervention to post-operation
Time frame: End-of-intervention to post-operation (mean 2.7 days; up to 7 days)
Post-intervention Plasma Trough Apalutamide Concentrations
Correlation between plasma apalutamide and percent change of PSA levels
Time frame: End-of-intervention (mean 4.8 weeks; up to 9 weeks)
Health-related Quality of Life (HRQOL)
Expanded Prostate Cancer Index Composite for Clinical Practice \[EPIC-CP\]. Higher scores indicate worse outcome (more symptoms). The minimum and maximum values for the total score are 0 to 60. A negative change indicates that the score decreased and therefore is a better outcome (reduced symptoms).
Time frame: Baseline to end of intervention (mean 4.8 weeks; up to 9 weeks)
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