Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

NCT03413137 | Unknown DMC

• 1 other identifier: 0618-17-RMC
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Biopsy

Keywords

Prostate cancer; transperineal mp-MRI-fusion/TRUS biopsies; mp-MRI fusion/TRUS transrectal biopsy

Outcome Measures

Primary Outcomes (1)

• Detection rate for clinically significant prostate cancer

  To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

  within 2 years

Secondary Outcomes (2)

• Percentage of cores positive per region of interest (ROI)

  within 2 years

• Amount of volume of cores positive per region of interest (ROI)

  within 2 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy

Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy

Arm B

ACTIVE COMPARATOR

A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy

Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy

Interventions

Transperineal mpMRI-US Fusion prostate biopsy PROCEDURE

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).

Also known as: MRI-US Fusion TP

Arm A; Arm B

Transrectal mpMRI-US Fusion prostate biopsy PROCEDURE

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.

Also known as: MRI-US Fusion TR

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
• Either primary biopsy or repeated biopsy
• Age 18-90.
• PI-RADS classification of 3-5

You may not qualify if:

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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center, Beilinson campus

Petah Tikva, 4941492, Israel

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Margel, MD PhD

  Rabn Medical Center, Beilinson Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivan Sela, B.Sc

CONTACT

+972(0)3-9376553; Sivanto1@clalit.org.il

Tzlil Tabachnik, M.Sc

CONTACT

+972(0)3-9376553; Tzlilta1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: January 29, 2018
• Study Start: December 11, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 30, 2018

Record last verified: 2017-10

Locations

IL (1)