Prostate Biopsy Clinical Trial
Official title:
A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy
Status | Recruiting |
Enrollment | 76 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center, Beilinson campus | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Percentage of cores positive per region of interest (ROI) | 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) | within 2 years | |
Secondary | Amount of volume of cores positive per region of interest (ROI) | 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) | within 2 years |
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