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ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation (SCORE)

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ClinicalTrials.gov Identifier: NCT03504761
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Precision Biopsy, Inc.

Brief Summary:
The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

Condition or disease Intervention/treatment Phase
Cellular Diagnosis, Prostate Cancer Device: ClariCore Optical Biopsy System Not Applicable

Detailed Description:
The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: ClariCore System
ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.
Device: ClariCore Optical Biopsy System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
Other Name: ClariCore System




Primary Outcome Measures :
  1. Validation of the tissue classification algorithm [ Time Frame: At time of procedure ]
    Correlate histopathology of tissue biopsy core samples with the tissue classification algorithm results obtained at the time of the procedure to validate the tissue classification algorithm.


Secondary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: At time of procedure ]
    The sensitivity and specificity of the ClariCore System will be calculated and reported.

  2. Cancer Detection Rate [ Time Frame: At time of procedure ]
    The cancer detection per core rate in the Targeted Cores that have been classified as suspicious will be determined and reported.


Other Outcome Measures:
  1. Identification of New or Clinically Significant Disease [ Time Frame: At time of procedure, at time of 7 day follow up ]
    The number of instances where a new or more clinically significant disease (Gleason 7 or greater) is diagnosed during collection of the Targeted Cores compared to the SOC Cores

  2. Adverse Event Incidence [ Time Frame: Up to 7 days post-procedure ]
    The cumulative incidence of adverse events related to the device or the procedure.

  3. Serious Adverse Event [ Time Frame: Up to 7 days post-procedure ]
    The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males > 22 years old
  • Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
  • Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume > 20cc and height at least 22mm)
  • Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria:

  • Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
  • Acute painful perianal disorder (i.e. rectal abscess)
  • Symptomatic, acute prostatitis
  • Surgical absence of a rectum or the presence of a rectal fistula
  • Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
  • Previous prostate intervention [Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift], not including previous prostate biopsy
  • Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history of a bleeding disorder (e.g. coagulopathy)
  • Prior pelvic irradiation
  • Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
  • Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
  • Patient has compromised immune system
  • 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 is not likely to comply with the protocol or follow up evaluation
  • Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
  • Patient is unable to provide legal Informed Consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504761


Contacts
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Contact: Amanda K Jonas, B.S. 510-676-0904 amanda.jonas@precisionbiopsy.com
Contact: Sierra Yearsley, B.S. 650-867-0927 sierra.yearsley@precisionbiopsy.com

Locations
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United States, Colorado
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact: Robin Dorsey    303-762-7155      
Principal Investigator: Larry Karsh, MD         
United States, Maryland
Brady Urological Institute, Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Robin Gurganus, RN, CCRC    410-614-6926    rgurganus@jhmi.edu   
Contact: Leslie Mangold, MS    410-955-2139    lmangold@jhmi.edu   
Principal Investigator: Michael A Gorin, M.D., Ph.D.         
United States, New York
NYU Langone Urology Associates Recruiting
New York, New York, United States, 10016
Contact: Elton Llukani       Elton.Llukani@nyumc.org   
Contact: James Wysock, MD       James.Wysock@nyumc.org   
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10021
Contact: Melissa Salerno, BS       salernom@mskcc.org   
Contact: Tanya Milan, MPH    646-227-2231    milanrot@mskcc.org   
Principal Investigator: Bafar Edhaie, M.D.         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Baiden    843-449-1010 ext 237    jbaiden@atlanticurologyclinics.com   
Principal Investigator: Neal Shore, MD         
Sub-Investigator: Kenneth Krzyzaniak, MD         
United States, Texas
Urology of San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Manuel R Hernandez    210-617-4116    manuel.hernandez@urologysa.com   
Principal Investigator: Daniel Saltzstein, MD         
Sponsors and Collaborators
Precision Biopsy, Inc.
Investigators
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Principal Investigator: Neal Shore, M.D. Carolina Urologic Research Center/Atlantic Urology Clinics

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Responsible Party: Precision Biopsy, Inc.
ClinicalTrials.gov Identifier: NCT03504761     History of Changes
Other Study ID Numbers: CIP-1010-B
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases