Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02761135
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 22, 2018
Sponsor:
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

Layout table for study information
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


Group/Cohort
Side-fire
Using side-fire technique during transrectal ultrasound.
End-fire
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT02761135


Locations
Layout table for location information
Sweden
Section of Urology, Department of surgery, Regional Hospital Växjö
Växjö, Kronoberg, Sweden
Sponsors and Collaborators
Kronoberg County Council
Investigators
Layout table for investigator information
Principal Investigator: Joakim Ortegren Section of Urology, Department of Surgery, Växjö County Hospital, Växjö, Sweden

Layout table for additonal information
Responsible Party: Kronoberg County Council
ClinicalTrials.gov 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
Side-fire
Prostate cancer
End-fire

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