A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Biopsy
- Sponsor
- Rabin Medical Center
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Detection rate for clinically significant prostate cancer
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
- •Either primary biopsy or repeated biopsy
- •PI-RADS classification of 3-5
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- 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)