Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

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: 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

Tracking Information
First Submitted Date  ICMJE October 15, 2017
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date January 30, 2018
Actual Study Start Date  ICMJE December 11, 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2018)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Official Title  ICMJE A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Brief Summary This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Prostate Biopsy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm A
    A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy
    Interventions:
    • Procedure: Transperineal mpMRI-US Fusion prostate biopsy
    • Procedure: Transrectal mpMRI-US Fusion prostate biopsy
  • Active Comparator: Arm B
    A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy
    Interventions:
    • Procedure: Transperineal mpMRI-US Fusion prostate biopsy
    • Procedure: Transrectal mpMRI-US Fusion prostate biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2018)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03413137
Other Study ID Numbers  ICMJE 0618-17-RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Margel, MD PhD Rabn Medical Center, Beilinson Campus
PRS Account Rabin Medical Center
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP