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

September 25, 2019 updated by: Institut Paoli-Calmettes
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
        • Principal Investigator:
          • Jochen WALZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HR-TRUS
HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of high resolution ultrasound
Time Frame: 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
From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precisions of high-resolution ultrasound and multiparametric MRI in the detection of lesions of prostate cancer.
Time Frame: 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.
From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Morphology of lesions not detected by high-resolution ultrasound
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

Exact Imaging

Investigators

  • Principal Investigator: Jochen WALZ, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXACTVU-IPC 2016-019
  • 2017-A01745-48 (Other Identifier: ANSM IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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