ClariCore Optical Biopsy System Used in TRUS (Trans-Rectal Ultrasound)-Guided Prostrate Biopsy

Study Overview
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Brief Summary
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The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.

Detailed Description
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The purpose of this study is to collect information on prostrate tissue biopsies using the ClariCore System. The ClariCore system is designed to improve how the tissue samples are being collected from the prostrate by using light sensors (fiber optics) that can see changes in the tissue. Researchers will study the data collected from the light sensor (optical readings) to develop a method (like a mathematical equation) that can be used to tell the difference between normal and cancerous prostrate tissue during the biopsy. What the researchers are hoping to learn from this study is if a light guided biopsy procedure can improve the accuracy of prostrate biopsy sampling.

Official Title
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Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing TRUS-Guided Prostrate Biopsy With or Without MR Fusion For Prostrate Tissue Classification Algorithm Development

Conditions
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Cellular Diagnosis, Prostate Cancer

Intervention / Treatment
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* Device: ClariCore System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure Exclusion Criteria: Contraindications to TRUS prostrate biopsy Acute painful perianal disorder Surgical absence of a rectum or the presence of a rectal fistula Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only) ---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI Previous prostrate surgeries Prior pelvic irradiation Active inflammatory bowel disease within the last 6 months Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g., significant cardiovascular conditions or allergies) Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection Bladder cancer (current or prior) Symptomatic acute prostatitis Actively taking blood thinning agents (with the exception of low dose aspirin [81 mg] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostrate) Neo-adjuvant hormonal therapy Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.) Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000) Patient is not likely to comply with the follow-up evaluation schedule Patient is participating in a clinical trial of another investigational drug or device Patient is mentally incompetent or a prisoner

Ages Eligible for Study
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Minimum Age: 22 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: ClariCore System<br>ClairCore System study designed for data collection to build the prostrate tissue classification algorithm. | Device: ClariCore System<br>* Data collection to build the prostrate tissue classification algorithm.<br>* Other names: ClariCore Optical Biopsy System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness | Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure. | Ath the time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pain | Pain shall be reported based on the patient-reported level of pain during the ClariCore System procedure and at 7 and 30 days post-procedure as measured on a 10 point numerical rating scale (NRS). | Up to 30 days post-procedure | 
| Incidence and frequency of adverse events | The secondary safety endpoint is the incidence and frequency of all Adverse Event's (both related and unrelated to the ClariCore System) reported during the study. | Up to 30 days post-procedure |