A prospective randomized controlled study on the Suppression of Prostate Cancer by Naftopidil (SNAP)

Daisuke Yamada, Haruki Kume, Hideyo Miyazaki, Mototsugu Tanaka, Munenori Takata, Yukari Uemura, Teppei Morikawa, Yutaka Enomoto, Motofumi Suzuki, Hiroaki Nishimatsu, Tohru Nakagawa, Tetsuya Fujimura (+3 others)
2018 Preventive Medicine and Community Health  
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
more » ... d, 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.
doi:10.15761/pmch.1000106 fatcat:tzsvb5solvey7dg4h2cmgkwvdi