JPRN-jRCT1052190098已完成4 期
Can localization of prostate cancer be improved with the use of BioJet system for prostate biopsy?
Akamatsu Shusuke0 个研究点目标入组 139 人开始时间: 2020年1月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
研究概览
简要总结
MRI/US fusion prostate needle biopsy using BioJET was useful to diagnose clinically significant cancer efficiently without increasing the diagnosis of non-significant indolent cancer. In addition, there was no adverse event associated with the procedure, and the procedure was proven to be safer than conventional transrectal needle biopsy. On the other hand, when the biopsy result was compared with the whole mount prostatectomy specimen, it was evident that especially during the period of initial experience,
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 90age old（—）
- 性别
- Male
入选标准
- •Patients that fulfill criteria I and either II or III who are eligible for prostatectomy and can give consent to the study.
- •I. Serum PSA elevation (>=2.5ng/ml, <=20ng/ml
- •II. suspicious of localized prostate cancer by digital rectal exam
- •III. suspicious of localized prostate cancer by MRI
- •Iv. age >=20, <90
排除标准
- •Either of the below.
- •I. patients who would not benefit from diagnoses of prostate cancer
- •II. patients with PSA >=20ng/ml, who are likely to have advanced prostate cancer
- •III. suspicious of advanced prostate cancer by digital rectal exam
- •IV. suspicious of advanced prostate cancer by MRI
- •V. patients who cannot undergo prostate biopsy due to coagulation disorders
- •VI. patients who are not eligible for spinal, sacral, or general anesthesia due to allergy
- •VII. patients who are not eligible for the study determined by the treating physician.
研究者
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