An observational study in Prostate Cancer, sponsored by Kronoberg County Council. Completed at 1 site in Sweden. Open to male participants. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by Kronoberg County Council · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 364 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Kronoberg County Council is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men admitted to Urological reception in Vaxjo and Ljungby for a first-time re-biopsy for investigating prostate cancer.
Exclusion Criteria:
Using side-fire technique during transrectal ultrasound.
Using end-fire technique during transrectal ultrasound.
Cancer detection
After finished study inclusion, data will be analyzed and presented within 12-18 months.
Time frame: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.
Plan to share: Yes
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Kronoberg County Council