ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

• ClinicalTrials.gov Identifier: NCT02773940
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2016
• Last Update Posted: February 15, 2019
• Sponsor: Precision Biopsy, Inc.
• Information provided by (Responsible Party): Precision Biopsy, Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

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

More Information

• Responsible Party: Precision Biopsy, Inc.
• ClinicalTrials.gov Identifier: NCT02773940
• Other Study ID Numbers: STP-1002
• First Posted: May 16, 2016
• 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:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases