Clinical trial NCT02761135: Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Biopsy technique
Transrectal ultrasonography probe
Side-fire
Prostate cancer
End-fire
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
First posted: 2016-05-04
Enrollment: 364
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men admitted to Urological reception in Vaxjo and Ljungby for a first-time re-biopsy for investigating prostate cancer.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cancer detection
timeFrame: Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Section of Urology, Department of surgery, Regional Hospital Växjö
state: Kronoberg
Study officials:
affiliation: Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden
name: Joakim Ortegren
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.