Urology of Virginia Case Series

Exact imaging

Status: Completed

Conditions: Cancer of the PROSTATE; Prostatic Neoplasm; Prostate Cancer

Treatments: Device: mpMRI guided prostate examination using PI-RADS v2; Device: Ultrasound guided prostate exam using SOC ultrasound system; Device: High-resolution micro-ultrasound guided prostate biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03035487

2016-UHR-001

Details and patient eligibility

About

The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.

The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).

These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.

In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

Full description

This trial will enroll nine men with an indication for a prostate biopsy.

The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.

The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.

Procedures in the study are:

• obtain informed consent for the subject
• image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
• perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
• prepare biopsy specimens for pathology
• record all procedure details in a case report form, including pathology and mpMRI reports

The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.

Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.

Enrollment: 9 patients

Sex: Male

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
2. PSA<50
3. Clinical stage < cT2c

Exclusion criteria

Patients will be excluded from being included in the investigation if any of the following is true:

1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
2. Men with known prostate volume (from prior imaging) of > 60cc
3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
4. Men who are unable to provide their own informed consent
5. Men who have contraindications to MRI or gadolinium chelate contrast

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Micro-ultrasound

Experimental group

Description:

Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities: * Low resolution transrectal ultrasound examination ("LR-TRUS") * Multi-parametric MRI ("mpMRI") examination performed according to the PI-RADS v2 protocol

Treatment:

Device: High-resolution micro-ultrasound guided prostate biopsy

Device: mpMRI guided prostate examination using PI-RADS v2

Device: Ultrasound guided prostate exam using SOC ultrasound system