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)?
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
- 否
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
