Prostate Cancer
Conditions
Keywords
multiparametric MRI, ExactVu ultrasound scanner, prostatectomy
Brief summary
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.
Detailed 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.
Interventions
DEVICEHR-TRUS
Medical procedures to be performed in the study consist of subject preparation and prostate imaging. The HR-TRUS exam will be done with a transrectal probe either the day before surgery, or in the OR right before surgery. The exam will be done in the same manner as during a regular transrectal ultrasound exam and no invasive procedures will be associated.
Sponsors
Exact Imaging
Institut Paoli-Calmettes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of high resolution ultrasound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | rate of adequately identified (positive or negative) lesions of prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer. | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | sensitivity, specificity, negative and positive predictive values of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer. |
| Morphology of lesions not detected by high-resolution ultrasound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | Volume and grade of lesions not detected by high-resolution ultrasound |
| Localization of lesions not detected by high-resolution ultrasound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | Location of lesions not detected by high-resolution ultrasound |
| Extra-prostatic extensions detected by high-resolution ultra-sound | From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days) | Extra-prostatic extensions and seminal vesicle invasions detected by high-resolution ultra-sound in positive and negative sectors |
Countries
France
Contacts
Primary ContactDominique Genre, MD
Backup ContactMargot Berline, MSc, MBA
Outcome results
None listed