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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02761135
Enrollment
364
Registered
2016-05-04
Start date
2011-01-31
Completion date
2018-03-31
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Biopsy technique, Transrectal ultrasonography probe, Side-fire, Prostate cancer, End-fire

Brief 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.

Interventions

None listed

Sponsors

Kronoberg County Council
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cancer detectionStudy 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026