Does End-fire Technique Increase Detection Rate of Prostate Cancer at First Re-biopsy Compared to Side-fire Technique?

NCT02761135 | Completed DMC

• 1 other identifier: Endfirestudie
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cancer detection

  After finished study inclusion, data will be analyzed and presented within 12-18 months.

  Study inclusion continues until 400 patients is included. Estimated time frame from study start 5 years.

Study Arms (2)

Side-fire

Using side-fire technique during transrectal ultrasound.

End-fire

Using end-fire technique during transrectal ultrasound.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• first re-biopsy
• PSA over 3ng/ml
• T1c to T2a palpatory finding

You may not qualify if:

• prostate cancer
• T2b or more advanced cancer
• more than one previous biopsy done

Sponsors & Collaborators

• Kronoberg County Council: lead

Study Sites (1)

Section of Urology, Department of surgery, Regional Hospital Växjö

Vaxjo, Kronoberg County, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31204873 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy cores from prostate.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Joakim Ortegren

  Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 4, 2016
• Study Start: January 1, 2011
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)