ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

NCT02773940 | Unknown

• 1 other identifier: STP-1002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (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

  Through study completion which ends at time of procedure completion

Secondary Outcomes (1)

• All adverse events reported during the procedure that are related to the ClariCore System

  Through study completion which ends at time of procedure completion

Study Arms (1)

ClariCore System

EXPERIMENTAL

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

Interventions

ClariCore System DEVICE

Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during a patient's already scheduled radical retropubic prostatectomy (RRP) surgery.

ClariCore System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Precision Biopsy, Inc.: lead

Study Sites (2)

Brady Urological Institute, Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alan W Partin, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• E. David Crawford, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 16, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)