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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01745-48 | Other Identifier | ANSM IDRCB |
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| Name | Class |
|---|---|
| Exact Imaging | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR-TRUS | HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR-TRUS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
male patients that are diagnosed with localized prostate cancer
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Genre, MD | Contact | (00) 4 91 22 37 78 | genred@ipc.unicancer.fr | |
| Margot Berline, MSc, MBA | Contact | (00) 4 91 22 33 14 | berlinem@ipc.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jochen Walz, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Recruiting | Marseille | Bouches Du Rhone | 13009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23558161 | Background | 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. | |
| 22118357 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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) |
| 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) |
| 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) |
| 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. |
| 26791931 | Background | 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. |
| 25264337 | Background | 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. |
| 17085122 | Background | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |