MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
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- STATUS
- Recruiting
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- End date
- Jan 15, 2025
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- participants needed
- 1586
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- sponsor
- Ardeshir Rastinehad
Summary
This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy. There are two biopsy approaches we are testing.
Patients will have a choice to be enrolled into the transrectal (TRUS) or transperineal (TP) arms at their discretion.
Description
The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.
Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.
Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy in patients undergoing the transrectal (TR) or transperineal (TP) biopsy approaches. The researchers are interested in learning which procedure is more useful in obtaining a clearer picture of the prostate which will in turn provide a better way of finding abnormalities. Each patient will act as their own control.
Details
| Condition | Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam, Prostate Cancer |
|---|---|
| Treatment | Prostate Biopsy, MR US Fusion Guided Prostate Biopsy, MR/TRUS Fusion Guided Prostate Biopsy |
| Clinical Study Identifier | NCT04599218 |
| Sponsor | Ardeshir Rastinehad |
| Last Modified on | 22 March 2022 |
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