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

Not Applicable

• Conditions: Cellular Diagnosis, Prostate Cancer
• Interventions: Device: ClariCore System

• Registration Number: NCT02928640
• Lead Sponsor: Precision Biopsy, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-01
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ClariCore System	ClariCore System	ClairCore System study designed for data collection to build the prostrate tissue classification algorithm.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness	Ath the time of procedure	Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure.

Secondary Outcome Measures

Name	Time	Method
Assessment of Pain	Up to 30 days post-procedure	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).
Incidence and frequency of adverse events	Up to 30 days post-procedure	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.

Trial Locations

Locations (5)

Johns Hopkins Brady Urological Institute- The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Associated Professionals of New York, PLLC; 🇺🇸 Syracuse, New York, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Comprehensive Urology; 🇺🇸 Royal Oak, Michigan, United States

The Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States