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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02761135
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):
Kronoberg County Council

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.

Condition or disease
Prostate Cancer

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Study Type : Observational
Actual Enrollment : 364 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Using side-fire technique during transrectal ultrasound.
Using end-fire technique during transrectal ultrasound.

Primary Outcome Measures :
  1. 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
Biopsy cores from prostate.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02761135

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Section of Urology, Department of surgery, Regional Hospital Växjö
Växjö, Kronoberg, Sweden
Sponsors and Collaborators
Kronoberg County Council
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Principal Investigator: Joakim Ortegren Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden

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Responsible Party: Kronoberg County Council Identifier: NCT02761135     History of Changes
Other Study ID Numbers: Endfirestudie
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Kronoberg County Council:
Biopsy technique
Transrectal ultrasonography probe
Prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases