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Background  Androgen receptor (AR) signaling inhibitors represent the standard treatment in metastatic castration resistance prostate cancer (mCRPC) patients. However, some patients display a primary resistance, and several studies investigated the role of the AR as a predictive biomarker of response to treatment. This study is aimed to evaluate the role of AR in liquid biopsy to predict clinical outcome to AR signaling inhibitors in mCRPC patients.    Methods  Six milliliters of plasma samples were collected before first-line treatment with abiraterone or enzalutamide. Circulating free DNA (cfDNA) and exosome-RNA were isolated for analysis of AR gain and AR splice variant 7 (AR-V7), respectively, by digital droplet PCR.    Results  Eighty-four mCRPC patients received abiraterone ( n  = 40) or enzalutamide ( n  = 44) as first-line therapy. Twelve patients (14.3%) presented  AR  gain and 30 (35.7%) AR-V7+ at baseline. Median progression-free survival (PFS) and overall survival (OS) were significantly longer in AR-V7− vs AR-V7+ patients (24.3 vs 5.4 months,  p  < 0.0001; not reached vs 16.2 months,  p  = 0.0001, respectively). Patients carrying the  AR  gain had a median PFS of 4.8 vs 24.3 months for  AR  normal patients ( p  < 0.0001). Median OS was significantly longer in  AR  normal vs patients with  AR  gain (not reached vs 8.17 months,  p  < 0.0001). A significant correlation between AR-V7 and  AR  gain was observed ( r  = 0.28;  p  = 0.01). The AR gain/AR-V7 combined analysis confirmed a strong predictive effect for biomarkers combination vs patients without any AR aberration (PFS 3.8 vs 28 month, respectively; OS 6.1 vs not reached, respectively;  p  < 0.0001).    Conclusions  The present study demonstrates that cfDNA and exosome-RNA are both a reliable source of AR variants and their combined detection in liquid biopsy predicts resistance to AR signaling inhibitors.

prostate cancer and prostatic diseases

Androgen receptor gain in circulating free DNA and splicing variant 7 in exosomes predict clinical outcome in CRPC patients treated with abiraterone and enzalutamide