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临床试验/NCT02761135
NCT02761135已完成不适用

Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique, in Investigating a Raised Prostatic Specific Antigen (PSA)?

Kronoberg County Council1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
364
试验地点
1
主要终点
Cancer detection

研究概览

简要总结

Prostate cancer is the most common cancer among men in Sweden. During investigation of suspected cancer transrectal ultrasound with needle biopsies from prostate leeds to diagnosis.

The most common technique today is side-fire where the needle enter the prostate in angle from the probe. In end-fire technique the needle enters the prostate at tip of probe without angle. The difference in techniques side-fire vs. end-fire affects the possibility to reach the ventral and apical aspects of prostate.

Today´s standard is at least five cores from each side of the prostate at first biopsy. If first sample is negative there will usually be another urological exam and a first re-biopsy.

The study aim to compare these two methods in cancer detection. The investigators' hypothesis is that when using end-fire technique at first re-biopsy, investigators find more cancers compared to side-fire.

Patients are prospectively randomized into two groups, both assessing 12 core biopsies according to study protocol.

Primary endpoint is cancer detection. Data will be collected about patient age, PSA-level, prostate size, digital rectal exam, hypoechogenic zones and length of cancers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • first re-biopsy
  • PSA over 3ng/ml
  • T1c to T2a palpatory finding

排除标准

  • prostate cancer
  • T2b or more advanced cancer
  • more than one previous biopsy done

结局指标

主要结局

Cancer detection

时间窗: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.

After finished study inclusion, data will be analyzed and presented within 12-18 months.

次要结局

未报告次要终点

研究者

发起方
Kronoberg County Council
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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