Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
NCT ID: NCT03859804
Last Updated: 2019-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2016-12-01
2019-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1
In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI
MRI- US fusion prostate biopsy (FPB)
FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)
Group 2
In Group 2, patients who had no suspected lesions or had a PI-RADS \<3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).
Standard transrectal 12 core biopsy
TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral
Interventions
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Standard transrectal 12 core biopsy
TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral
MRI- US fusion prostate biopsy (FPB)
FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having suspicious digital rectal examination
* having multi-parametric prostate MRI before prostate biopsy
* Having MRI defined lesions which were PIRADS - 3 -4-5
Exclusion Criteria
* previous negative biopsy
* neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
* patients underwent biopsy under general anesthesia,
* having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold
50 Years
75 Years
MALE
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Abdullah Demirtas
Abdullah Demirtas, Md, Assoc. Prof.
Principal Investigators
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Abdullah T Demirtaş, MD
Role: PRINCIPAL_INVESTIGATOR
Erciyes University Faculty of Medicine Department of Urolgoy
Locations
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Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, , Turkey (Türkiye)
Countries
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References
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Other Identifiers
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2014/508
Identifier Type: -
Identifier Source: org_study_id
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