Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer (EXACTVU)

Institut Paoli-Calmettes

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: HR-TRUS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03679819

2017-A01745-48 (Other Identifier)

EXACTVU-IPC 2016-019

Details and patient eligibility

About

The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.

Full description

The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference. The analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions. With this approach it is possible to calculate the sensitivity, specificity, negative predictive value, positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate. These results are of importance when the ExactVu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies.

Enrollment: 50 estimated patients

Sex: Male

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. men > 35 years age and <80 years of age
2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
3. staging by standard procedures show localized disease (<cT4)
4. PSA < 50ng/ml
5. Access to the rectum for trans rectal ultrasound
6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
7. Signed written informed consent prior to any screening procedures being performed

Exclusion criteria

1. Patient with absence of diagnosis of prostate cancer
2. Patient with metastatic prostate cancer
3. Patient with rectal amputation
4. Patient with contraindications for MRI
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Trial design

50 participants in 1 patient group

HR-TRUS

Description:

HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer

Treatment:

Device: HR-TRUS