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

• Conditions: Prostate Cancer
• Interventions: Device: HR-TRUS

• Registration Number: NCT03679819
• Lead Sponsor: Institut Paoli-Calmettes

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.

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-20
• Status Verified: 2019-09
• Study Start: 2019-09-05
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26
• Primary Completion: 2021-04-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France