Prostate CancerEcho-CADNCT02618200
Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
A study testing 3D prostate ultrasound in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3D prostate ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to 31 Aug 2017
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for radical prostatectomy
- Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
- Informed consent signed
- Patient affiliated to the French Health Insurance system
Who cannot join
- History of prostatic surgery or radiation therapy (prostatic or pelvic)
- History of hormone therapy for prostate cancer
- Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
- Patient on protection of the court, under supervision or under trusteeship
- Inability to express a consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Service Service de radiologie
Lyon, 69437
About this study
Official title: Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.
In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.
- Conditions
- Prostate Cancer
- Being tested
- 3D prostate ultrasound
- Keywords
- Prostate cancer, Computer-Aided Diagnosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D prostate ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| 3D prostate ultrasound | Experimental | 3D prostate ultrasound will be performed in patients the day before radical prostatectomy Receives: Device: 3D prostate ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtention of 3D ultrasound images
Measured: the day before radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start1 Feb 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618200
- Sponsor's protocol ID
- 69HCL15_0100
- Acronym
- Echo-CAD
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaouen T, Souchon R, Moldovan PC, Bratan F, Duran A, Hoang-Dinh A, Di Franco F, Debeer S, Dubreuil-Chambardel M, Arfi N, Ruffion A, Colombel M, Crouzet S, Gonindard-Melodelima C, Rouviere O. Characterization of high-grade prostate cancer at multiparametric MRI using a radiomic-based computer-aided diagnosis system as standalone and second reader. Diagn Interv Imaging. 2023 Oct;104(10):465-476. doi: 10.1016/j.diii.2023.04.006. Epub 2023 May 20.
PubMed 37345961Couchoux T, Jaouen T, Melodelima-Gonindard C, Baseilhac P, Branchu A, Arfi N, Aziza R, Barry Delongchamps N, Bladou F, Bratan F, Brunelle S, Colin P, Correas JM, Cornud F, Descotes JL, Eschwege P, Fiard G, Guillaume B, Grange R, Grenier N, Lang H, Lefevre F, Malavaud B, Marcelin C, Moldovan PC, Mottet N, Mozer P, Potiron E, Portalez D, Puech P, Renard-Penna R, Roumiguie M, Roy C, Timsit MO, Tricard T, Villers A, Walz J, Debeer S, Mansuy A, Mege-Lechevallier F, Decaussin-Petrucci M, Badet L, Colombel M, Ruffion A, Crouzet S, Rabilloud M, Souchon R, Rouviere O. Performance of a Region of Interest-based Algorithm in Diagnosing International Society of Urological Pathology Grade Group >/=2 Prostate Cancer on the MRI-FIRST Database-CAD-FIRST Study. Eur Urol Oncol. 2024 Oct;7(5):1113-1122. doi: 10.1016/j.euo.2024.03.003. Epub 2024 Mar 16.
PubMed 38493072
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02618200
- Acronym / sponsor ID
- Echo-CAD / 69HCL15_0100
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Computer-Aided Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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.
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.
In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D prostate ultrasound | Experimental | Device: 3D prostate ultrasound3D prostate ultrasound will be performed in patients the day before radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient referred for radical prostatectomy
- Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
- Informed consent signed
- Patient affiliated to the French Health Insurance system
Key exclusion criteria (5 listed)
- History of prostatic surgery or radiation therapy (prostatic or pelvic)
- History of hormone therapy for prostate cancer
- Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
- Patient on protection of the court, under supervision or under trusteeship
- Inability to express a 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 |
|---|---|---|
| 3D prostate ultrasound | Device | 3D prostate ultrasound |
Primary outcome
Obtention of 3D ultrasound images
Time frame: the day before radical prostatectomy
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 19 Dec 2025.
- Results publication: PubMed 37345961Jaouen T, Souchon R, Moldovan PC, Bratan F, Duran A, Hoang-Dinh A, Di Franco F, Debeer S, Dubreuil-Chambardel M, Arfi N, Ruffion A, Colombel M, Crouzet S, Gonindard-Melodelima C, Rouviere O. Characterization of high-grade prostate cancer at multiparametric MRI using a radiomic-based computer-aided diagnosis system as standalone and second reader. Diagn Interv Imaging. 2023 Oct;104(10):465-476. doi: 10.1016/j.diii.2023.04.006. Epub 2023 May 20.
- Results publication: PubMed 38493072Couchoux T, Jaouen T, Melodelima-Gonindard C, Baseilhac P, Branchu A, Arfi N, Aziza R, Barry Delongchamps N, Bladou F, Bratan F, Brunelle S, Colin P, Correas JM, Cornud F, Descotes JL, Eschwege P, Fiard G, Guillaume B, Grange R, Grenier N, Lang H, Lefevre F, Malavaud B, Marcelin C, Moldovan PC, Mottet N, Mozer P, Potiron E, Portalez D, Puech P, Renard-Penna R, Roumiguie M, Roy C, Timsit MO, Tricard T, Villers A, Walz J, Debeer S, Mansuy A, Mege-Lechevallier F, Decaussin-Petrucci M, Badet L, Colombel M, Ruffion A, Crouzet S, Rabilloud M, Souchon R, Rouviere O. Performance of a Region of Interest-based Algorithm in Diagnosing International Society of Urological Pathology Grade Group >/=2 Prostate Cancer on the MRI-FIRST Database-CAD-FIRST Study. Eur Urol Oncol. 2024 Oct;7(5):1113-1122. doi: 10.1016/j.euo.2024.03.003. Epub 2024 Mar 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D prostate ultrasound in people with Prostate Cancer, run by Hospices Civils de Lyon 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 4 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 19 Dec 2025. 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?
Obtention of 3D ultrasound images (time frame: the day before radical prostatectomy). 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 NCT02618200, which also lists 2 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 19 Dec 2025.