Prostate CancerEXACTVUNCT03679819
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
An observational study of Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HR-TRUS
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2021to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- men > 35 years age and <80 years of age
- diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
- staging by standard procedures show localized disease (<cT4)
- PSA < 50ng/ml
- Access to the rectum for trans rectal ultrasound
- Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
- Signed written informed consent prior to any screening procedures being performed
Who cannot join
- Patient with absence of diagnosis of prostate cancer
- Patient with metastatic prostate cancer
- Patient with rectal amputation
- Patient with contraindications for MRI
- Patient in urgency situation, adult under legal protection, or unable to give his consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- HR-TRUS
- Keywords
- multiparametric MRI, ExactVu ultrasound scanner, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-TRUSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HR-TRUS | HR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer Receives: Device: HR-TRUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of high resolution ultrasound
rate of adequately identified (positive or negative) lesions of prostate cancer
Measured: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Secondary outcomes (4)
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.
Measured: 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
Volume and grade of lesions not detected by high-resolution ultrasound
Measured: 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
Measured: 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
Measured: From date of HR-TRUS exam until the date of Prostate biopsy data are obtained (average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 May 2021
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Exact Imaging
- Responsible party
- Sponsor
- Investigators
- Jochen Walz, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679819
- Sponsor's protocol ID
- EXACTVU-IPC 2016-019
- Other IDs
- 2017-A01745-48
- Acronym
- EXACTVU
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2018
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23558161Walz 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.
PubMed 22118357Ghai 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.
PubMed 26791931Boehm 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.
PubMed 25264337Villers 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.
PubMed 17085122
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03679819
- Acronym / sponsor ID
- EXACTVU / EXACTVU-IPC 2016-019
- Conditions
- Prostate Cancer
- Keywords
- multiparametric MRI, ExactVu ultrasound scanner, prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Exact Imaging
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR-TRUS | – | Device: HR-TRUSHR-TRUS for the detection of prostate cancer in men scheduled for radical prostatectomy for localized prostate cancer |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- men > 35 years age and <80 years of age
- diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
- staging by standard procedures show localized disease (<cT4)
- PSA < 50ng/ml
- Access to the rectum for trans rectal ultrasound
Key exclusion criteria (5 listed)
- Patient with absence of diagnosis of prostate cancer
- Patient with metastatic prostate cancer
- Patient with rectal amputation
- Patient with contraindications for MRI
- Patient in urgency situation, adult under legal protection, or unable to give his consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-TRUSMedical 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. | Device | HR-TRUS |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 23558161Pavlovich 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.
- Background: PubMed 22118357Walz 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.
- Background: PubMed 26791931Ghai 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.
- Background: PubMed 25264337Boehm 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.
- Background: PubMed 17085122Villers 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Walz, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679819, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.