An interventional study of Core Needle TRUS Needle biopsy (Transrectal ultrasound) and Core Needle MRI/US image fusion guided needle biopsy in Prostate Cancer, sponsored by Philips Healthcare. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Philips Healthcare · Not applicable, Interventional, and Diagnostic
This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.
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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.
Exclusion Criteria:
Patient receiving core needle TRUS biopsy (Standard of care biopsy)
Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
Procedure: Core Needle MRI/US image fusion guided needle biopsy
Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate
Also known as: Core Needle biopsy, TRUS needle biopsy (Transrectal ultrasound)
Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies
Also known as: Core Needle biopsy, MRI/US image fusion guided needle biopsy
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.
Time frame: Day 1
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Philips Healthcare