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

Prostate Cancer Clinical Trial

— EXACTVU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03679819
• Other study ID #: EXACTVU-IPC 2016-019
• Secondary ID: 2017-A01745-48
• Status: Recruiting
• Start date: September 5, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2019
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre, MD
• Phone: (00) 4 91 22 37 78
• Email: genred[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• HR-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.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Exact Imaging

Country where clinical trial is conducted

France, 

References & Publications (5)

Boehm K, Salomon G, Beyer B, Schiffmann J, Simonis K, Graefen M, Budaeus L. Shear wave elastography for localization of prostate cancer lesions and assessment of elasticity thresholds: implications for targeted biopsies and active surveillance protocols. J Urol. 2015 Mar;193(3):794-800. doi: 10.1016/j.juro.2014.09.100. Epub 2014 Sep 28. — View Citation

Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12. — View Citation

Pavlovich CP, Cornish TC, Mullins JK, Fradin J, Mettee LZ, Connor JT, Reese AC, Askin FB, Luck R, Epstein JI, Burke HB. High-resolution transrectal ultrasound: pilot study of a novel technique for imaging clinically localized prostate cancer. Urol Oncol. 2014 Jan;32(1):34.e27-32. doi: 10.1016/j.urolonc.2013.01.006. Epub 2013 Apr 2. — View Citation

Villers A, Puech P, Mouton D, Leroy X, Ballereau C, Lemaitre L. Dynamic contrast enhanced, pelvic phased array magnetic resonance imaging of localized prostate cancer for predicting tumor volume: correlation with radical prostatectomy findings. J Urol. 2006 Dec;176(6 Pt 1):2432-7. — View Citation

Walz J, Marcy M, Maubon T, Brunelle S, Laroche J, Gravis G, Salem N, Bladou F. [Real time elastography in the diagnosis of prostate cancer: comparison of preoperative imaging and histology after radical prostatectomy]. Prog Urol. 2011 Dec;21(13):925-31. doi: 10.1016/j.purol.2011.04.006. Epub 2011 Jun 2. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of high resolution ultrasound	rate of adequately identified (positive or negative) lesions of prostate cancer	From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Secondary	Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.	sensitivity, specificity, negative and positive predictive values 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)
Secondary	Morphology of lesions not detected by high-resolution ultrasound	Volume and grade 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)
Secondary	Localization of lesions not detected by high-resolution ultrasound	Location 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)
Secondary	Extra-prostatic extensions detected by high-resolution ultra-sound	Extra-prostatic extensions and seminal vesicle invasions detected by high-resolution ultra-sound in positive and negative sectors	From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)