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This will be a prospective cohort trial that compares 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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | A Transperineal mpMRI-US Fusion prostate biopsy followed by a 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Amount of volume of cores positive per region of interest (ROI) |
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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
Age 18-90.
PI-RADS classification of 3-5
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| David Margel, MD PhD | Rabn Medical Center, Beilinson Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Beilinson campus | Recruiting | Petah Tikva | 4941492 | Israel |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
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|
| 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. |
|
|
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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |