Clinical Trials Directory

Trials / Completed

CompletedNCT02761135

Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?

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)?

Status
Completed
Phase
Study type
Observational
Enrollment
364 (actual)
Sponsor
Kronoberg County Council · Other Government
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2011-01-01
Primary completion
2018-03-01
Completion
2018-03-01
First posted
2016-05-04
Last updated
2018-05-22

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02761135. Inclusion in this directory is not an endorsement.