Clinical trial NCT03504761: ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cellular Diagnosis, Prostate Cancer
Lead sponsor: Precision Biopsy, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 325
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 this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

Detailed description: The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).

Eligibility criteria: Inclusion Criteria:

* Males \> 22 years old
* Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
* Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume \> 20cc and height at least 22mm)
* Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria:

* Any anatomical or co-morbidity contraindications to TRUS prostate 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 \[Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)\], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift\], not including previous prostate biopsy
* Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) 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
* 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
* Patient is unable to provide legal Informed Consent

Primary outcomes:
measure: Validation of the tissue classification algorithm
timeFrame: At time of procedure
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: At time of procedure
measure: Cancer Detection Rate
timeFrame: At time of procedure
Other outcomes:
measure: Identification of New or Clinically Significant Disease
timeFrame: At time of procedure, at time of 7 day follow up
measure: Adverse Event Incidence
timeFrame: Up to 7 days post-procedure
measure: Serious Adverse Event
timeFrame: Up to 7 days post-procedure
Locations:
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Baltimore
country: United States
facility: Brady Urological Institute, Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: NYU Langone Urology Associates
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: Urology of San Antonio
state: Texas
Study officials:
affiliation: Carolina Urologic Research Center/Atlantic Urology Clinics
name: Neal Shore, M.D.
role: PRINCIPAL_INVESTIGATOR
References: