Clinical trial NCT03734575: ClariCore System Used in Transperineal Prostate Biopsy
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Precision Biopsy, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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. Ultrasound images corresponding to each needle insertion and T2-weighted MR scans will be saved for the purpose of further algorithm development that will provide physicians with real time tissue classification in conjunction with location information from the ultrasound imaging.

Eligibility criteria: Inclusion Criteria:

1. Males per Investigator assessment appropriate for transperineal prostate biopsy
2. Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
3. Prostate volume \> 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
4. 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

Exclusion Criteria:

1. Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping biopsy
2. Acute painful perianal disorder (i.e. rectal abscess)
3. Symptomatic, acute prostatitis
4. Surgical absence of a rectum or the presence of a rectal fistula
5. Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
6. Previous prostate intervention \[TURP (bipolar, monopolar, laser)\] TUMT, HIFU, Cryo, Rezum, Urolift\], not including previous prostate biopsy
7. 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)
8. Prior pelvic irradiation
9. 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)
10. Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
11. Patient has compromised immune system, in the opinion of the Investigator
12. Active inflammatory bowel disease within the last 6 months
13. 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)
14. Patient is not likely to comply with the protocol or follow up evaluation
15. Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study

Primary outcomes:
measure: Correlation of histopathology of tissue with ultrasound images and spectral data
timeFrame: At time of procedure
Secondary outcomes:
measure: Incidence of Adverse Events (Safety)
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The James Buchanan Brady Urological Institute and Department of Urology
state: Maryland
city: New York
country: United States
facility: NYU Langone Urology Associates
state: New York
Study officials:
affiliation: NYU Langone Urology Associates
name: James Wysock, MD
role: PRINCIPAL_INVESTIGATOR
References: