MR/TRUS Fusion Guided Prostate Biopsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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 at 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 prostate biopsies. 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. Each patient will act as their own control.

Official Title
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MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer

Conditions
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Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam

Intervention / Treatment
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* Procedure: prostate biopsy
* Procedure: MR US Fusion Guided Prostate Biopsy
* Device: MR/TRUS Fusion Guided Prostate Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines. Age greater than 18 years. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation. The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained. Ability to tolerate sedation and or general anesthesia if required. PSA >2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy Able to tolerate a ultrasound guided biopsy Exclusion Criteria: Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure. Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI) Patients with uncorrectable coagulopathies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Males with Prostate Cancer<br>Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy. | Procedure: prostate biopsy<br>* standard of care<br>Procedure: MR US Fusion Guided Prostate Biopsy<br>* Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy<br>* Other names: Fusion Biopsy;Device: MR/TRUS Fusion Guided Prostate Biopsy<br>* 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 prostate biopsies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Prostate Cancer | Incidence of diagnosing subjects with prostate cancer with MR visible lesions | Day 0 - day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy | 1 month | 
| Pirads score | The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion. | 1 month | 
| Gleason score | The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted Prostate Biopsy