Clinical trial NCT02928640: ClariCore Optical Biopsy System Used in TRUS (Trans-Rectal Ultrasound)-Guided Prostrate Biopsy
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing TRUS-Guided Prostrate Biopsy With or Without MR Fusion For Prostrate Tissue Classification Algorithm Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cellular Diagnosis, Prostate Cancer
Lead sponsor: Precision Biopsy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-10
Enrollment: 200
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.

Detailed description: The purpose of this study is to collect information on prostrate tissue biopsies using the ClariCore System. The ClariCore system is designed to improve how the tissue samples are being collected from the prostrate by using light sensors (fiber optics) that can see changes in the tissue. Researchers will study the data collected from the light sensor (optical readings) to develop a method (like a mathematical equation) that can be used to tell the difference between normal and cancerous prostrate tissue during the biopsy. What the researchers are hoping to learn from this study is if a light guided biopsy procedure can improve the accuracy of prostrate biopsy sampling.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
* Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate 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:

* Contraindications to TRUS prostrate biopsy

  * Acute painful perianal disorder
  * Surgical absence of a rectum or the presence of a rectal fistula
* Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only)

  ---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
* Previous prostrate surgeries
* Prior pelvic irradiation
* 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 has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
* Bladder cancer (current or prior)
* Symptomatic acute prostatitis
* Actively taking blood thinning agents (with the exception of low dose aspirin \[81 mg\] Plavix, Coumadin, etc.) or severe 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 prostrate)
* Neo-adjuvant hormonal therapy
* Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
* Patient has a 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

Primary outcomes:
measure: Primary Effectiveness
timeFrame: Ath the time of procedure
Secondary outcomes:
measure: Assessment of Pain
timeFrame: Up to 30 days post-procedure
measure: Incidence and frequency of adverse events
timeFrame: Up to 30 days post-procedure
Other outcomes:
measure: Technical Success
timeFrame: Until clinical study closure, at time of 30 day follow up
measure: Clinical Success
timeFrame: Until clinical study closure, at time of 30 day follow up
measure: Negative Predictive Value
timeFrame: Until clinical trial closure, at time of 30 days follow up
Locations:
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Brady Urological Institute- The Johns Hopkins Hospital
state: Maryland
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Syracuse
country: United States
facility: Associated Professionals of New York, PLLC
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
Study officials:
affiliation: Sponsor GmbH
name: Sierra Yearly
role: STUDY_DIRECTOR
References: