Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.

Detailed Description
-----------------
The objective of this study is to determine the effectiveness of the Focal-Fusion Bx device at finding clinically relevant prostate cancer. A multiparametric MRI examination will be carried out prior to study enrollment. Probable cancerous regions (regions of interest, ROI) will be identified, and these ROIs will be used as targets during the biopsy. Three prostate sampling methods will be conducted in the same session on all patients. These include: i) Focal-Fusion Bx targeted biopsy ii) Cognitive fusion targeted biopsy and iii) Systematic (untargeted) biopsy. Trans-rectal ultrasound (TRUS) imaging will be conducted with BK Flex Focus Ultrasound system (Analogic Corporation, Peabody, MA). Primary hypothesis: The technique used to acquire the biopsy samples will impact the proportion of clinically relevant cancers by improving the specificity of detecting clinically significant cancers. It is hypothesized that Focal-Fusion Bx biopsies will diagnose more high risk cancers and fewer low-risk cancers than non-targeted systematic biopsies.

Official Title
-----------------
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device in Patients With an Elevated PSA and a Positive Multiparametric MRI

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: Focal-Fusion Bx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male subjects up to 80 years of age Candidates for fusion biopsy Elevated PSA levels MP-MRI with lesions having a Prostate Imaging Reporting and Data System (PI-RADS) score greater than or equal to 3 (determined by a trained radiologist) Subject is willing and able to read, understand and sign the Informed Consent Form document Exclusion Criteria: Previous treatment for prostate cancer Any contraindication to a standard TRUS prostate biopsy procedure Refusal to sign the Informed Consent document

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI-ultrasound fusion device<br>Using the Focal-Fusion Bx device, the urologist will fuse ('coregister') the MRI to the TRUS imaging | Device: Focal-Fusion Bx<br>* The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.<br>* Other names: MRI-ultrasound fusion device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of biopsy cores positive for clinically significant cancer. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of men diagnosed with clinically significant and clinically insignificant cancer. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Biopsy, Focal Healthcare, Fusion Targeted Biopsy, High Risk Cancer, Imaging, Diagnostic, Ultrasound, Multiparametric Magnetic Resonance Imaging (MP-MRI), MRI-Ultrasound Fusion, Focal-Fusion Bx