ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy

Status unconfirmed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02773940

Run by

Precision Biopsy, Inc.

People needed

100

Starts

2016-05-01

Expected to finish

2020-06-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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