Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer

NCT02618200 | Completed

• 1 other identifier: 69HCL15_0100
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Prostate cancer; Computer-Aided Diagnosis

Outcome Measures

Primary Outcomes (1)

• Obtention of 3D ultrasound images

  the day before radical prostatectomy

Study Arms (1)

3D prostate ultrasound

EXPERIMENTAL

3D prostate ultrasound will be performed in patients the day before radical prostatectomy

Device: 3D prostate ultrasound

Interventions

3D prostate ultrasound DEVICE

3D prostate ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot - Service Service de radiologie

Lyon, 69437, France

Location

Related Publications (2)

• 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.

  PMID: 37345961 RESULT

• Couchoux 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.

  PMID: 38493072 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 1, 2015
• Study Start: February 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)