ClariCore System Used in Transperineal Prostate Biopsy

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Conditions studied: Prostate Cancer

In brief

The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach.

Key facts

Study ID

NCT03734575

Run by

Precision Biopsy, Inc.

People needed

60

Starts

2018-10-10

Expected to finish

2019-07-09

Last updated by the study team

2019-07-11

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males per Investigator assessment appropriate for transperineal prostate biopsy
• Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
• Prostate volume > 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
• Patient must be able to provide legal consent and signs an IRB (Institutional Review Board)/EC (Ethics Committee) approved Informed Consent form to participate in the study prior to any study mandated determinations or procedure

You may not qualify if…

• Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping biopsy
• Acute painful perianal disorder (i.e. rectal abscess)
• Symptomatic, acute prostatitis
• Surgical absence of a rectum or the presence of a rectal fistula
• Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
• Previous prostate intervention [TURP (bipolar, monopolar, laser)] TUMT, HIFU, Cryo, Rezum, Urolift], not including previous prostate biopsy
• Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; or history of a bleeding disorder (e.g. coagulopathy)
• Prior pelvic irradiation
• Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
• Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
• Patient has compromised immune system, in the opinion of the Investigator
• Active inflammatory bowel disease within the last 6 months
• 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 is not likely to comply with the protocol or follow up evaluation
• Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study

Where it is running

• The James Buchanan Brady Urological Institute and Department of Urology — Baltimore, Maryland, United States
• NYU Langone Urology Associates — New York, New York, United States

Full record on ClinicalTrials.gov

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