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

K

Kronoberg County Council

Status

Completed

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02761135
Endfirestudie

Details and patient eligibility

About

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.

Enrollment

364 patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

364 participants in 2 patient groups

Side-fire
Description:
Using side-fire technique during transrectal ultrasound.
End-fire
Description:
Using end-fire technique during transrectal ultrasound.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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