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临床试验/JPRN-UMIN000022862
JPRN-UMIN000022862已完成未知

A prospective randomized controlled study on Suppression of Prostate Cancer by naftopidil (SNAP) - Suppression of prostate cancer by naftopidil (SNAP)

niversity of Tokyo0 个研究点目标入组 1,200 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
1,200

研究概览

简要总结

Case registration completed, follow-up

研究设计

研究类型
Interventional

入排标准

年龄范围
40years-old 至 80years-old(—)
性别
Male

入选标准

  • 未提供

排除标准

  • (2) Exclusion criteria 1) Patients who were given a diagnosis of prostate cancer or prostatic atypical (Atypical) (PIN: prostatic intraepithelial neoplasia is accepted) 2) Patients with the history of oral administration of anti-androgenic medicine or 5 alpha reductase inhibitor in the 6 months before the measurement of the serum PSA value the last time before prostate needle biopsy 3) Patients with the history of oral administration of naftopidil in the 3 months before prostate needle biopsy 4) Patients not having indication for oral administration of alpha1 adrenergic receptor blockers in patients with severe dysuria accompanied with prostatic hyperplasia (states such as urinary retention, urethral catheter placement, the intermittent urethral catheterization) 5) Patients who are currently taking steroid medicine on consecutive days 6) Patients with active urogenital infection (including acute prostatitis) 7) Patients with the history of malignant tumor (however, the cases that the disease was cured radically) 8) Patients who received antineoplastic agents (including therapeutic purposes other than malignant tumors) in the last 3 months before biopsy (for sustained release formulations, during drug release period) 9) Patients with severe hepatic dysfunction (AST (GOT) or ALT (GPT) of more than 100IU) 10) Patient with severe renal dysfunction (serum creatinine of more than 2.0 mg/dl) 11) Patients who are judged inappropriate by investigators

研究者

发起方
niversity of Tokyo

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