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

NCT ID: NCT03679819

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2021-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

HR-TRUS

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

HR-TRUS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Exact Imaging

INDUSTRY

Sponsor Role: collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jochen Walz, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Site Status: RECRUITING

Countries

France

Central Contacts

Dominique Genre, MD

Role: CONTACT

genred@ipc.unicancer.fr

(00) 4 91 22 37 78

Margot Berline, MSc, MBA

Role: CONTACT

berlinem@ipc.unicancer.fr

(00) 4 91 22 33 14

Facility Contacts

Dominique Genre, MD

Role: primary

drci.up@ipc.unicancer.fr

0033491223778

References

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.

Reference Type: BACKGROUND

PMID: 23558161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22118357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26791931 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25264337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17085122 (View on PubMed)

Other Identifiers

2017-A01745-48

Identifier Type: OTHER

Identifier Source: secondary_id

EXACTVU-IPC 2016-019

Identifier Type: -

Identifier Source: org_study_id