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Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System (CHANGE)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sample

Follow up questionnaire

Human reading of prostate MR images (PI-RADSv2.1).

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Men over 18 years of age
Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies
PSA ≤ 30 ng / ml
Clinical stage ≤ T2c
Affiliation or beneficiary of a social security scheme

Exclusion Criteria:

Men over 80 years of age
PSA> 30 ng / ml
Stage T3 or T4 on digital rectal examination
Previous prostate biopsy performed within 12 months
History of prostate cancer diagnosed by biopsy or endourethral resection.
History of pelvic radiotherapy regardless of the cause.
History of total or focal treatment for prostate cancer.
History of hormone therapy
MRI performed more than 3 months before biopsy
Prostate MRI performed on a machine other than the center's machines accredited for the study.
Presence of a hip prosthesis
Contraindication to performing an MRI
Contraindication to performing prostate biopsy
Patient subject to a legal protection measure or deprived of liberty
Subject participating or having participated in interventional medical research with an exclusion period still in progress
Misunderstanding of the French language

Sites / Locations

Department of radiology and urology, CHU Pellegrin
Department of urology and Radiology, CHU Grenoble Alpes
Department of radiology and urology, CHU de Lille
Department of radiology and urology, Hôpital Edouard HerriotRecruiting
Department of radiology and urology, Hôpital Saint Joseph Saint Luc
Department of Radiology and Urology, Hopital Européen Marseille
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
Department of Urology, Clinique Beausoleil Montpellier
Department of urology and Radiology
Department Urology, Clinique urologique Nantes Atlantis
Department of radiology and urology, Hôpital la Pitié Salpêtrière
Department of radiology, Hôpital Necker
Department of urology and radiology, CHLS
Department of Urology, Quint Fonsegrives
Department of urology, CHU de Saint-Étienne Hôpital Nord
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prospective multicenter cohort

Arm Description

Constitution of a prospective multicenter cohort of 420 patients with suspected prostate cancer that will undergo prostate multiparametric MRI followed by systematic and targeted biopsy. When available (i.e., at the end of the RHU PERFUSE program, November 2022), the final version of the CAD will be used retrospectively to assess the risk that the prostate/targeted lesions harbor ISUP ≥2 cancer. In addition, a blood sample will be taken in all patients before the biopsy to assess the performance of the PHI index in predicting the presence of ISUP ≥2 cancer at systematic and targeted biopsy (ancillary study, secondary objective).

Outcomes

Primary Outcome Measures

Evaluation of the non-inferiority of the AUC of the final CAD developed in the PERFUSE program for the detection of ISUP ≥2 cancers, as compared to that of the PI-RADSv2.1 score (human reading), at per-patient analysis.

AUC of the final CAD and of the PI-RADS version 2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI, at per-patient analysis. A priori-defined non-inferiority margin: 5 percentage points.

Secondary Outcome Measures

Comparison of the specificities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis.

Specificity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis).

Comparison of the sensitivities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis .

Sensitivity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis)

Comparison of the AUCs of the final CAD and of the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.

AUC of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.

Comparison of the sensitivities and specificities of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.

Sensitivity and specificity of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.

Assessment of the impact of biopsy setting, magnetic field strength, human reader's experience, biopsy guidance technique and prostate volume on the AUC of the CAD and the PI-RADSv2.1 scores for the detection of ISUP cancers ≥2, at per-patient analysis.

Analysis of the effect of biopsy setting, magnetic field strength, reader's experience, biopsy guidance technique and prostate volume on the AUC of the final CAD and the PI-RADv2.1, at per-patient analysis.

Comparison of the AUC of the PHI index to that of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers, at per-patient analysis.

AUC of the PHI index for the detection of cancers ISUP ≥2 on systematic and targeted biopsies performed after MRI, at per-patient analysis.

Estimation of the number of biopsies avoided and the number of ISUP cancers ≥2 missed for the following diagnostic strategies:

Number of biopsies avoided and number of ISUP cancers ≥2 missed according to the strategies described below: PHI index then, if positive, MRI and biopsies regardless of the MRI result (MRI used only to guide targeted biopsies). PHI index then, if positive, MRI then, if positive, targeted biopsies. Biopsy only if MRI positive; no PHI index. MRI then, if positive, PHI index then, if positive, targeted biopsies. MRI then, if negative, PHI index; biopsy for patients with a positive MRI or with a negative MRI but a positive PHI index PHI index and MRI for all patients; biopsy if positive PHI index AND positive MRI. PHI index and MRI for all patients; biopsy if positive PHI OR positive MRI.

Full Information

NCT ID

NCT04732156

First Posted

January 18, 2021

Last Updated

December 8, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04732156

Brief Title

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

Acronym

CHANGE

Official Title

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 14, 2021 (Actual)

Primary Completion Date

June 15, 2026 (Anticipated)

Study Completion Date

June 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Multiparametric MRI of the prostate is recommended before each prostate biopsy. It identifies suspicious areas which will then be the subject of targeted biopsies. However, MRI suffers from low specificity and moderate inter-reader reproducibility, including with the use of the PI-RADS version 2.1 score. We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system (CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and performed well on a database of patients who had prostate MRI before biopsy at the Hopices civils de Lyon. However, one of the weaknesses of artificial intelligence systems is their low robustness when tested on MRI images from different manufacturers or institutions. The goal of the CHANGE study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric MRI followed by systematic and targeted prostate biopsies. The cohort will be used for the final external validation of the CAD developed in PERFUSE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prospective multicenter cohort

Arm Type

Other

Arm Description

Intervention Type

Biological

Intervention Name(s)

Blood sample

Intervention Description

Measurement of PHI Index

Intervention Type

Other

Intervention Name(s)

Follow up questionnaire

Intervention Description

3 years after inclusion

Intervention Type

Diagnostic Test

Intervention Name(s)

Human reading of prostate MR images (PI-RADSv2.1).

Intervention Description

The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)

Primary Outcome Measure Information:

Title

Description

Time Frame

Through recruitment completion, an average of 2 years

Secondary Outcome Measure Information:

Title

Comparison of the specificities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis.

Description

Time Frame

Through recruitment completion, an average of 2 years

Title

Comparison of the sensitivities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis .

Description

Time Frame

Through recruitment completion, an average of 2 years

Title

Comparison of the AUCs of the final CAD and of the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.

Description

AUC of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.

Time Frame

Through recruitment completion, an average of 2 years

Title

Comparison of the sensitivities and specificities of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.

Description

Sensitivity and specificity of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.

Time Frame

Through study completion, an average of 5 years

Title

Description

Time Frame

Through recruitment completion, an average of 2 years

Title

Comparison of the AUC of the PHI index to that of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers, at per-patient analysis.

Description

AUC of the PHI index for the detection of cancers ISUP ≥2 on systematic and targeted biopsies performed after MRI, at per-patient analysis.

Time Frame

Through recruitment completion, an average of 2 years

Title

Estimation of the number of biopsies avoided and the number of ISUP cancers ≥2 missed for the following diagnostic strategies:

Description

Time Frame

Through recruitment completion, an average of 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men over 18 years of age Patient with clinical suspicion of prostate cancer referred for a multiparametric MRI of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies PSA ≤ 30 ng / ml Clinical stage ≤ T2c Affiliation or beneficiary of a social security scheme Exclusion Criteria: Men over 80 years of age PSA> 30 ng / ml Stage T3 or T4 on digital rectal examination Previous prostate biopsy performed within 12 months History of prostate cancer diagnosed by biopsy or endourethral resection. History of pelvic radiotherapy regardless of the cause. History of total or focal treatment for prostate cancer. History of hormone therapy MRI performed more than 3 months before biopsy Prostate MRI performed on a machine other than the center's machines accredited for the study. Presence of a hip prosthesis Contraindication to performing an MRI Contraindication to performing prostate biopsy Patient subject to a legal protection measure or deprived of liberty Subject participating or having participated in interventional medical research with an exclusion period still in progress Misunderstanding of the French language

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olivier ROUVIERE, Pr

Phone

4 72 11 61 70

Ext

+33

olivier.rouviere@chu-lyon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Adeline MANSUY, PhD

Phone

4 72 11 51 70

Ext

+33

adeline.mansuy@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier ROUVIERE, Pr

Organizational Affiliation

Service d'imagerie, pavillon B Hôpital Edouard Herriot

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of radiology and urology, CHU Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clément Marcellin, Dr

Phone

5 56 79 55 99

Ext

+33

clement.marcelin@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Franck Bladou, Pr

Facility Name

Department of urology and Radiology, CHU Grenoble Alpes

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bénedicte Guillaume, Dr

Phone

4 76767984

Ext

+33

bguillaume@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Gaelle Fiard, MD

Facility Name

Department of radiology and urology, CHU de Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Puech, Pr

Phone

3 20 44 61 91

Ext

+33

philippe.puech@chru-lille.fr

First Name & Middle Initial & Last Name & Degree

Arnauld Villers, Pr

Facility Name

Department of radiology and urology, Hôpital Edouard Herriot

City

Lyon

ZIP/Postal Code

69003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Rouvière, Pr

Phone

4 72 11 61 67

Ext

+33

olivier.rouviere@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Sébastien Crouzet, Pr

Facility Name

Department of radiology and urology, Hôpital Saint Joseph Saint Luc

City

Lyon

ZIP/Postal Code

69007

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Favie Bratan, MD

Phone

4 78 61 88 00

Ext

+33

fbratan@ch-stjoseph-stluc-lyon.fr

First Name & Middle Initial & Last Name & Degree

Nicolas Arfi, MD

Facility Name

Department of Radiology and Urology, Hopital Européen Marseille

City

Marseille

ZIP/Postal Code

13003

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc André, MD

First Name & Middle Initial & Last Name & Degree

Antoine Van Hove, MD

Facility Name

Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

City

Marseille

ZIP/Postal Code

13273

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serge Brunelle, MD

Phone

4 91 22 34 19

Ext

+33

brunelles@ipc.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Jochen Walz, MD

Facility Name

Department of Urology, Clinique Beausoleil Montpellier

City

Montpellier

ZIP/Postal Code

34070

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grégoire Poinas, Dr

Phone

4 67 459365

Ext

+33

g.poinas@languedoc-mutualite.fr

Facility Name

Department of urology and Radiology

City

Montpellier

ZIP/Postal Code

34090

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ingrid Millet, Pr

Phone

6 78 88 71 74

Ext

+33

i-millet@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Rodolphe Thuret, Pr

Facility Name

Department Urology, Clinique urologique Nantes Atlantis

City

Nantes

ZIP/Postal Code

44800

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Potiron, MD

Phone

2 28 03 04 44

Ext

+33

ep@cliniqueuro.com

Facility Name

Department of radiology and urology, Hôpital la Pitié Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raphaele renardpenna, Pr

Phone

1 42 17 82 15

Ext

+33

raphaele.renardpenna@aphp.fr

First Name & Middle Initial & Last Name & Degree

Pierre Mozer, Pr

Facility Name

Department of radiology, Hôpital Necker

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jean-michel correas, Pr

Phone

1 44 49 41 40

Ext

+33

jean-michel.correas@aphp.fr

Facility Name

Department of urology and radiology, CHLS

City

Pierre-Bénite

ZIP/Postal Code

69310

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Moldovan, MD

Phone

4 72 11 12 31

Ext

+33

paul-cezar.moldovan@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Alain Ruffion, Pr

Facility Name

Department of Urology, Quint Fonsegrives

City

Quint Fonsegrives

ZIP/Postal Code

31130

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume Ploussard, MD/PhD

Phone

5 32 02 72 02

Ext

+33

gploussard@capio.fr

Facility Name

Department of urology, CHU de Saint-Étienne Hôpital Nord

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Mottet-Auselot, Pr

Phone

4 77 82 83 31

Ext

+33

nicolas.mottet@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

Remi Grange, Dr

Facility Name

Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Catherine Roy, Pr

Phone

3 69 55 07 31

Ext

+33

catherine.roy@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Thibault Tricard, Pr

Facility Name

Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

City

Toulouse

ZIP/Postal Code

231059

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

aziza richard, MD

Phone

5 31 15 60 60

Ext

+33

aziza.richard@iuct-oncopole.fr

First Name & Middle Initial & Last Name & Degree

bernard malavaud, Pr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.

Citations:

PubMed Identifier

35140147

Citation

Rouviere O, Souchon R, Lartizien C, Mansuy A, Magaud L, Colom M, Dubreuil-Chambardel M, Debeer S, Jaouen T, Duran A, Rippert P, Riche B, Monini C, Vlaeminck-Guillem V, Haesebaert J, Rabilloud M, Crouzet S. Detection of ISUP >/=2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study). BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.

Results Reference

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Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

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