MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study
The efficacy of targeting lesions for surgery may be limited by the visibility of a target
during the procedure. The successful outcome of surgical intervention depends upon accurate
device placement, which may be very challenging in certain settings, such as when a kidney
tumor only is visible for a brief moment during the transient arterial phase of a contrast
injection, and soon disappearing on dynamic imaging.
Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate
biopsies. With PSA (Prostate SPecific Antigen) screening and improvements in
ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the
standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core
prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.
Prostate MR imaging with the addition of an endorectal-coil probe and a 3 Tesla magnet
dramatically improves diagnostic utility dramatically but biopsies are difficult,
time-consuming, and require specialized equipment, which increases the cost significantly.
To meet this challenge TRUS images are overlaid on a previously obtained prostate MRI,
combined with an electromagnetic tracking system. The urologist then performs directed
prostate biopsies at MR-identified targets in addition to the standard 12-14 core biopsies.
This study will consist of comparison of the standard of care (TRUS guided prostate biopsy)
with the protocol biopsy which consists of a TRUS guided prostate biopsy and a MR/US fusion
tracked prostate biopsy. Each patient will act as their own control.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of prostate lesions
To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.
United States: Institutional Review Board
|The Arthur Smith Institute for Urology||New Hyde Park, New York 11040|