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Prostate CancerCHANGENCT04732156

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

A study testing Blood sample, Follow up questionnaire and Human reading of prostate MR images (PI-RADSv2.1). in people with Prostate Cancer, run by Hospices Civils de Lyon at 17 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Blood sample, Follow up questionnaire and Human reading of prostate MR images (PI-RADSv2.1).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
17 sitesFrance
Study dates
14 Apr 2021to 15 Jun 2026
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

Olivier ROUVIERE, Pr contact

4 72 11 61 70 ext. +33

olivier.rouviere@chu-lyon.fr

Adeline MANSUY, PhD contact

4 72 11 51 70 ext. +33

adeline.mansuy@chu-lyon.fr

17 sites in 1 country

France17 sites, 17 recruiting

  • Department of radiology and urology, CHU Pellegrin

    Bordeaux, 33076

    Clément Marcellin, Dr, 5 56 79 55 99 ext. +33, clement.marcelin@chu-bordeaux.fr

    Franck Bladou, Pr

    Not yet recruiting

  • Department of urology and Radiology, CHU Grenoble Alpes

    Grenoble, 38043

    Bénedicte Guillaume, Dr, 4 76767984 ext. +33, bguillaume@chu-grenoble.fr

    Gaelle Fiard, MD

    Not yet recruiting

  • Department of radiology and urology, CHU de Lille

    Lille, 59037

    Philippe Puech, Pr, 3 20 44 61 91 ext. +33, philippe.puech@chru-lille.fr

    Arnauld Villers, Pr

    Not yet recruiting

  • Department of radiology and urology, Hôpital Edouard Herriot

    Lyon, 69003

    Olivier Rouvière, Pr, 4 72 11 61 67 ext. +33, olivier.rouviere@chu-lyon.fr

    Sébastien Crouzet, Pr

    Recruiting

  • Department of radiology and urology, Hôpital Saint Joseph Saint Luc

    Lyon, 69007

    Favie Bratan, MD, 4 78 61 88 00 ext. +33, fbratan@ch-stjoseph-stluc-lyon.fr

    Nicolas Arfi, MD

    Not yet recruiting

  • Department of Radiology and Urology, Hopital Européen Marseille

    Marseille, 13003

    Marc André, MD

    Antoine Van Hove, MD

    Not yet recruiting

  • Department of Radiology and Urology, Institut Paoli-Calmettes Marseille

    Marseille, 13273

    Serge Brunelle, MD, 4 91 22 34 19 ext. +33, brunelles@ipc.unicancer.fr

    Jochen Walz, MD

    Not yet recruiting

  • Department of Urology, Clinique Beausoleil Montpellier

    Montpellier, 34070

    Grégoire Poinas, Dr, 4 67 459365 ext. +33, g.poinas@languedoc-mutualite.fr

    Not yet recruiting

  • Department of urology and Radiology

    Montpellier, 34090

    Ingrid Millet, Pr, 6 78 88 71 74 ext. +33, i-millet@chu-montpellier.fr

    Rodolphe Thuret, Pr

    Not yet recruiting

  • Department Urology, Clinique urologique Nantes Atlantis

    Nantes, 44800

    Eric Potiron, MD, 2 28 03 04 44 ext. +33, ep@cliniqueuro.com

    Not yet recruiting

  • Department of radiology and urology, Hôpital la Pitié Salpêtrière

    Paris, 75013

    Raphaele renardpenna, Pr, 1 42 17 82 15 ext. +33, raphaele.renardpenna@aphp.fr

    Pierre Mozer, Pr

    Not yet recruiting

  • Department of radiology, Hôpital Necker

    Paris, 75015

    jean-michel correas, Pr, 1 44 49 41 40 ext. +33, jean-michel.correas@aphp.fr

    Not yet recruiting

  • Department of urology and radiology, CHLS

    Pierre-Bénite, 69310

    Paul Moldovan, MD, 4 72 11 12 31 ext. +33, paul-cezar.moldovan@chu-lyon.fr

    Alain Ruffion, Pr

    Not yet recruiting

  • Department of Urology, Quint Fonsegrives

    Quint-Fonsegrives, 31130

    Guillaume Ploussard, MD/PhD, 5 32 02 72 02 ext. +33, gploussard@capio.fr

    Not yet recruiting

  • Department of urology, CHU de Saint-Étienne Hôpital Nord

    Saint-Etienne, 42055

    Nicolas Mottet-Auselot, Pr, 4 77 82 83 31 ext. +33, nicolas.mottet@chu-st-etienne.fr

    Remi Grange, Dr

    Not yet recruiting

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

    Strasbourg, 67000

    Catherine Roy, Pr, 3 69 55 07 31 ext. +33, catherine.roy@chru-strasbourg.fr

    Thibault Tricard, Pr

    Not yet recruiting

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

    Toulouse, 231059

    aziza richard, MD, 5 31 15 60 60 ext. +33, aziza.richard@iuct-oncopole.fr

    bernard malavaud, Pr

    Not yet recruiting

Other trials in France

About this study

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.

Read more

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.

Conditions
Prostate Cancer
Being tested
Blood sample, Follow up questionnaire, Human reading of prostate MR images (PI-RADSv2.1).
Keywords
prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleBiological

    Measurement of PHI Index

  • Follow up questionnaireOther

    3 years after inclusion

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

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

Study groups in NCT04732156
Study groupRoleWhat they receive
Prospective multicenter cohortOtherConstitution 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).
Receives: Biological: Blood sample; Other: Follow up questionnaire; Diagnostic Test: Human reading of prostate MR images (PI-RADSv2.1).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through recruitment completion, an average of 2 years

Secondary outcomes (7)

  1. 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).

    Measured: Through recruitment completion, an average of 2 years

  2. 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)

    Measured: Through recruitment completion, an average of 2 years

  3. 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.

    Measured: Through recruitment completion, an average of 2 years

  4. 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.

    Measured: Through study completion, an average of 5 years

  5. 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.

    Measured: Through recruitment completion, an average of 2 years

  6. 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.

    Measured: Through recruitment completion, an average of 2 years

  7. 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:

    1. PHI index then, if positive, MRI and biopsies regardless of the MRI result (MRI used only to guide targeted biopsies).
    2. PHI index then, if positive, MRI then, if positive, targeted biopsies.
    3. Biopsy only if MRI positive; no PHI index.
    4. MRI then, if positive, PHI index then, if positive, targeted biopsies.
    5. MRI then, if negative, PHI index; biopsy for patients with a positive MRI or with a negative MRI but a positive PHI index
    6. PHI index and MRI for all patients; biopsy if positive PHI index AND positive MRI.
    7. PHI index and MRI for all patients; biopsy if positive PHI OR positive MRI.

    Measured: Through recruitment completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2021
  2. Study start14 Apr 2021
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

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
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04732156
Sponsor's protocol ID
69HCL20_0769
Acronym
CHANGE
Status last verified
Feb 2024
First submitted
18 Jan 2021
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35140147

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample, Follow up questionnaire and Human reading of prostate MR images (PI-RADSv2.1). in people with Prostate Cancer, run by Hospices Civils de Lyon at 17 sites 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olivier ROUVIERE, Pr (4 72 11 61 70 ext. +33, olivier.rouviere@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Through recruitment completion, an average of 2 years). 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 NCT04732156, which also lists 1 linked publication.

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 28 Feb 2024.

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