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ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773940
Recruitment Status : Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Precision Biopsy, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: ClariCore System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Multi-Center Study of the ClariCore™ Optical Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy For Prostate Tissue Classification Algorithm Development
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02773940


Locations
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United States, Maryland
Brady Urological Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Precision Biopsy, Inc.
Investigators
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Principal Investigator: Alan W Partin, M.D., Ph.D. Johns Hopkins University
Principal Investigator: E. David Crawford, M.D. University of Colorado, Denver
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Responsible Party: Precision Biopsy, Inc.
ClinicalTrials.gov Identifier: NCT02773940    
Other Study ID Numbers: STP-1002
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases