D. Yamada, H. Kume, Hideyo Miyazaki
2018
Citations
0
Influential Citations
0
Citations
Quality indicators
Journal
Journal name not available for this finding
Abstract
Background: Naftopidil is an alpha-1 adrenergic receptor-blocking agent commonly used for benign prostatic hyperplasia (BPH) in Japan. Our previous retrospective study demonstrated a significantly lower incidence of prostate cancer in BPH men treated with naftopidil (1.8%) compared with those with tamsulosin (3.1%). Currently we are attempting to confirm the suppressive effect of naftopidil on prostate carcinogenesis in a prospective randomized study. Methods: This multicenter, randomized, open-label clinical trial will enroll men who are proven negative for cancer after the first prostate biopsy at the University of Tokyo Hospital and its 11 affiliated hospitals. Upon agreement, these subjects will be randomly assigned to the oral naftopidil administration group (550 cases) or the non-administration control group (550 cases) and have serum prostate specific antigen (PSA) levels measured once a year for 5 years at longest. Prostate biopsy is to be repeated when the follow-up serum PSA level exceeds the precedent value. The primary endpoint is the time period to the diagnosis of prostate cancer. Prostate cancer-free survival calculated by Kaplan-Meier method is used to analyze inter-group differences by log-rank test. Discussion: This is the first prospective randomized clinical study to verify whether naftopidil reduces the incidence of prostate cancer in men negative for cancer by first biopsy.