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Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

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ClinicalTrials.gov Identifier: NCT03413137
Recruitment Status : Unknown
Verified October 2017 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : January 29, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy

Condition or disease Intervention/treatment Phase
Prostate Biopsy Procedure: Transperineal mpMRI-US Fusion prostate biopsy Procedure: Transrectal mpMRI-US Fusion prostate biopsy Not Applicable

Detailed Description:

This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).

First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.

The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Arm A
A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy
Procedure: Transperineal mpMRI-US Fusion prostate biopsy
mpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI).
Other Name: MRI-US Fusion TP

Procedure: Transrectal mpMRI-US Fusion prostate biopsy
using the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging.
Other Name: MRI-US Fusion TR

Active Comparator: Arm B
A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy
Procedure: Transperineal mpMRI-US Fusion prostate biopsy
mpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI).
Other Name: MRI-US Fusion TP

Procedure: Transrectal mpMRI-US Fusion prostate biopsy
using the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging.
Other Name: MRI-US Fusion TR




Primary Outcome Measures :
  1. Detection rate for clinically significant prostate cancer [ Time Frame: within 2 years ]
    To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.


Secondary Outcome Measures :
  1. Percentage of cores positive per region of interest (ROI) [ Time Frame: within 2 years ]
    To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Percentage of cores positive per region of interest (ROI)

  2. Amount of volume of cores positive per region of interest (ROI) [ Time Frame: within 2 years ]
    To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Amount of volume of cores positive per region of interest (ROI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.

    • Either primary biopsy or repeated biopsy

  2. Age 18-90.
  3. PI-RADS classification of 3-5

Exclusion Criteria:

  1. Men who do not have an MRI of the prostate.
  2. PI-RADS classification of 2 or lower
  3. Men who were diagnosed with prostate cancer and have begun treatment

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): NCT03413137


Contacts
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Contact: Sivan Sela, B.Sc +972(0)3-9376553 Sivanto1@clalit.org.il
Contact: Tzlil Tabachnik, M.Sc +972(0)3-9376553 Tzlilta1@clalit.org.il

Locations
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Israel
Rabin Medical Center, Beilinson campus Recruiting
Petach Tikva, Israel, 4941492
Contact: Sivan Sela, B.Sc    +972-3-9376553    Sivanto1@clalit.org.il   
Contact: Tzlil Tabachnik, M.Sc    +972-3-9376553    Tzlilba1@clalit.org.il   
Principal Investigator: David Margel, MD PhD         
Sub-Investigator: Jack Baniel, MD         
Sub-Investigator: Daniel Kedar, MD         
Sub-Investigator: Daniel Halstuch, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: David Margel, MD PhD Rabn Medical Center, Beilinson Campus
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03413137    
Other Study ID Numbers: 0618-17-RMC
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rabin Medical Center:
Prostate cancer
transperineal mp-MRI-fusion/TRUS biopsies
mp-MRI fusion/TRUS transrectal biopsy