Clinical trial NCT03679819: Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Official title: Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: multiparametric MRI
ExactVu ultrasound scanner
prostatectomy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Exact Imaging
First posted: 2018-09-20
Enrollment: 50
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male patients that are diagnosed with localized prostate cancer by prostate biopsy and that are scheduled for radical prostatectomy as treatment for their disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy of high resolution ultrasound
timeFrame: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Secondary outcomes:
measure: Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.
timeFrame: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
measure: Morphology of lesions not detected by high-resolution ultrasound
timeFrame: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
measure: Localization of lesions not detected by high-resolution ultrasound
timeFrame: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
measure: Extra-prostatic extensions detected by high-resolution ultra-sound
timeFrame: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jochen Walz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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. doi: 10.1016/j.juro.2006.08.007.