ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

February 12, 2019 updated by: Precision Biopsy, Inc.

Prospective, Multi-Center Study of the ClariCore™ Optical Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy For Prostate Tissue Classification Algorithm Development

The purpose of the study is to collect information on prostate tissue biopsies collected with the ClariCore System during a radical prostatectomy procedure. The ClariCore System is designed to improve how biopsies are taken from the prostate by using light sensors (fiber optics) that can see changes in the tissue. The information collected from the study will be used to develop a method to tell the difference between normal and suspicious tissue to help guide the physician during a biopsy procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The overall objective of this study is to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore System for the purpose of algorithm development.

The system algorithm will be trained to identify real-time in vivo 'Normal' versus 'Suspicious' prostate tissue. The 'Normal' or 'Suspicious' assignment will be based on the optical signal principle component parameters of the measured signal when compared to a threshold to be derived from pathologically known values of suspicious (or possibly cancerous) and normal (or non-cancerous) measurements in prostate tissue.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Brady Urological Institute, Johns Hopkins Hospital
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patient scheduled for radical retropubic prostatectomy
  • Prostate volume > 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or 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:

  • Patient opted for robotic (da Vinci robot) or laparoscopic surgery
  • 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)
  • Actively taking blood thinning agents (with the exception of low dose aspirin {81 mg}, Plavix, Coumadin etc.) or severe medical 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 prostate)
  • Neo-adjuvant hormonal therapy
  • Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
  • Patient has 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during the patient's already scheduled radical retropubic prostatectomy (RRP) surgery.
Device: ClariCore System
Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during a patient's already scheduled radical retropubic prostatectomy (RRP) surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optical spectra measurements will be correlated with biopsy tissue core samples in patients with known prostate cancer undergoing radical retropubic prostatectomy surgery to develop a prostate tissue classification database
Time Frame: Through study completion which ends at time of procedure completion
Through study completion which ends at time of procedure completion

Secondary Outcome Measures

Outcome Measure
Time Frame
All adverse events reported during the procedure that are related to the ClariCore System
Time Frame: Through study completion which ends at time of procedure completion
Through study completion which ends at time of procedure completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision Biopsy, Inc.

Investigators

  • Principal Investigator: Alan W Partin, M.D., Ph.D., Johns Hopkins University
  • Principal Investigator: E. David Crawford, M.D., University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STP-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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