Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?
NCT ID: NCT02761135
Last Updated: 2018-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
364 participants
OBSERVATIONAL
2011-01-31
2018-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Side-fire
Using side-fire technique during transrectal ultrasound.
No interventions assigned to this group
End-fire
Using end-fire technique during transrectal ultrasound.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* PSA over 3ng/ml
* T1c to T2a palpatory finding
Exclusion Criteria
* T2b or more advanced cancer
* more than one previous biopsy done
MALE
No
Sponsors
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Kronoberg County Council
OTHER_GOV
Responsible Party
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Principal Investigators
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Joakim Ortegren
Role: PRINCIPAL_INVESTIGATOR
Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden
Locations
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Section of Urology, Department of surgery, Regional Hospital Växjö
Vaxjo, Kronoberg County, Sweden
Countries
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References
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Ortegren J, Holmberg JT, Lekas E, Mana S, Martensson S, Richthoff J, Sundqvist P, Kjolhede H, Bratt O, Liedberg F. A randomised trial comparing two protocols for transrectal prostate repeat biopsy: six lateral posterior plus six anterior cores versus a standard posterior 12-core biopsy. Scand J Urol. 2019 Aug;53(4):217-221. doi: 10.1080/21681805.2019.1628102. Epub 2019 Jun 17.
Other Identifiers
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Endfirestudie
Identifier Type: -
Identifier Source: org_study_id
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