To prospectively evaluate the detection rate of prostate cancer, and to identify the risk factors of prostate cancer detection after a 1-year administration of dutasteride and first negative prostate biopsy. Patients with benign prostatic hyperplasia who presented high prostate-specific antigen levels after the first negative prostate biopsy were administered 0.5mg dutasteride daily for 1year. They underwent a repeat prostate biopsy after 1year. The primary end-point was the detection rate of prostate cancer. The secondary end-point was the ability of prostate-specific antigen kinetics to predict prostate cancer detection. Prostate-specific antigen was measured before the initial prostate biopsy and at 6, 9 and 12months after starting dutasteride. Patients were classified into a prostate cancer and a non-prostate cancer group. Prostate cancer was detected in 15 of 149 participants (10.1%). The total prostate-specific antigen change between the prostate cancer and non-prostate cancer group at 1year was significantly different (P=0.002). Although prostate-specific antigen levels at baseline did not significantly differ between study groups (P=0.102), prostate-specific antigen levels at 6, 9 and 12months were significantly different (P=0.002, P=0.001 and P<0.001, respectively). The mean reduction rate of prostate-specific antigen density between the prostate cancer and non-prostate cancer group at 1year was significantly different (-4.25±76.5% vs -38.0±28.7%, P=0.001). Using a multivariate analysis, a >10% increase of prostate-specific antigen density at 1year post-dutasteride treatment was the only predictive risk factor for prostate cancer after the first negative prostate biopsy (odds ratio 11.238, 95% confidence interval 3.112-40.577, P<0.001). In the present study cohort, >10% increase in prostate-specific antigen density represented the only significant predictive risk factor for prostate cancer diagnosis in patients with elevated prostate-specific antigen after the first negative prostate biopsy.
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