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The therapeutic landscape of castration-resistant prostate cancer (CRPC) has rapidly expanded. There is a need to develop noninvasive biomarkers to guide treatment. We established a highly sensitive method for analyzing androgen receptor gene ( AR ) copy numbers (CN) and mutations in plasma circulating cell-free DNA (cfDNA) and evaluated the  AR  statuses of patients with CRPC.  AR  amplification was detectable in VCaP cell line ( AR  amplified) genomic DNA (gDNA) diluted to 1.0% by digital PCR (dPCR).  AR  mutation were detectable in LNCaP cell line ( AR  T878A mutated) gDNA diluted to 0.1% and 1.0% by dPCR and target sequencing, respectively. Next, we analyzed  AR  status in cfDNA from 102 patients.  AR  amplification and mutations were detected in 47 and 25 patients, respectively. As a biomarker,  AR  aberrations in pretreatment cfDNA were associated with poor response to abiraterone, but not enzalutamide. In serial cfDNA analysis from 41 patients, most  AR  aberrations at baseline diminished with effective treatments, whereas in some patients with disease progression,  AR  amplification or mutations emerged. The analysis of  AR  in cfDNA is feasible and informative procedure for treating patients with CRPC. cfDNA may become a useful biomarker for precision medicine in CRPC.

scientific reports

Clinical utility of androgen receptor gene aberrations in circulating cell-free DNA as a biomarker for treatment of castration-resistant prostate cancer