Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?
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|ClinicalTrials.gov Identifier: NCT02761135|
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 22, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||364 participants|
|Official Title:||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)?|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Using side-fire technique during transrectal ultrasound.
Using end-fire technique during transrectal ultrasound.
- Cancer detection [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761135
|Section of Urology, Department of surgery, Regional Hospital Växjö|
|Växjö, Kronoberg, Sweden|
|Principal Investigator:||Joakim Ortegren||Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden|