ARFI Imaging for Targeted Prostate Biopsy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.

Official Title
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Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Acoustic radiation force impulse (ARFI)
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy; Men who are willing to participate in the study; Subjects must freely sign informed consent to enroll in the study; Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation. 18 years or older Exclusion Criteria: Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy; Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc); standard pharmacological treatment of BPH is allowable Men who are mentally impaired and cannot give written consent; Men with anomalies of the rectum.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acoustic radiation force impulse (ARFI)<br>Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy. | Device: Acoustic radiation force impulse (ARFI)<br>* Sound waves are sent in a series and are expected to push on the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system<br>|
| Active Comparator: MR-ultrasound fusion<br>Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy. | Device: Ultrasound<br>* Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCa detection rate |  | Up to 30 mins | 
| Length of cancerous tissue |  | Up to 30 mins | 
| Grade of cancerous tissue |  | Up to 30 mins | 
| Gleason score | A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score. Higher numbers indicate more aggressive cancers. | Up to 30 mins | 
| Gleason Grade Group | A newer technique to stratify prostate cancer risk, 5 categories. | Up to 30 mins | 
| Clinically significant disease (CSD) as measured by biopsy score. |  | Up to 30 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transrectal Ultrasound, Prostate biopsy