Prostate CancerMULTINCT04299997
Evaluation of the PI-RADS v2.1 Score Using Multiple Readers
An observational study of Prostate Cancer and Urological Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Urological Cancer
- What is being tested?
- Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.
- How many people
- 171 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 30 Jun 2020
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with mpMRI and subsequent biopsy between September 2015 and July 2016 (see above).
Who may be able to join
- Prostate mpMRI and biopsy performed at our institution
- Performed between September 2015 and July 2016
- No history of prostate cancer at the time of the mpMRI
Who cannot join
- Patients who already had treatment for prostate cancer
- Patients under Active Surveillance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study
The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.
The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 171 prostate MRIs using 21 readers of varying experience.
Read more
Twenty-one readers (14 seniors and 7 juniors) from 9 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.
Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.
- Conditions
- Prostate Cancer, Urological Cancer
- Being tested
- Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.
- Keywords
- multiparametric MRI, ISUP, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.Other
- Ass of targeted suspect lesions On each mpMRI,radiologist will contour lesions that were targeted at subsequent biopsy based on reports. Contours will be disclosed to readers who will assess,for each lesion:
- Likert score("gut feeling"ie subjective ass of the likelihood that lesion is clinically significant prostate cancer(5-level scale))
- PI-RADSv2, PI-RADSv2.1 score(by strictly applying the published PI-RADS criteria)
- EPE score(ie the likelihood of extraprostatic extension;5-level subjective scale without predefined criteria)
- Max diameter
- Def of add suspect lesions Readers could define suspect"additional targets"(AT);for each AT,they will provide the same criteria. It is expected that, for these suspect AT,at least one score is≥3
- Ass of lobes Scores of prostate lobes will be automatically calculated based on 2 previous steps of reading. However,in lobes with no suspect lesion,readers could define whether same criteria are1or2,in peripheral zone and transition zone
| Study group | Role | What they receive |
|---|---|---|
| 171 mpMRIs corresponding to consecutive patients who underwent | The mpMRIs were performed on a 1.5T GE MR unit or on a 3T GE or Philips MR units. All mpMRIs included T2-weighted imaging, diffusion-weighted imaging (maximal b value: 2000 s/mm²) and dynamic contrast-enhanced imaging. Receives: Other: Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
Analysis at the lesion level will be favored to get an evaluation of the influence of experience of readers scoring the exact same set of lesions.
Measured: June 2020.
Secondary outcomes (9)
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at biopsy, at the lesionlobe and patient levels
Measured: June 2020
Inter-reader concordance of the PI-RADS v2.1 score, at lesion, lobe and patient levels
Measured: June 2020
AUC of the PI-RADS v2 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion, lobe and patient levels
Measured: June 2020
Inter-reader concordance of the PI-RADS v2 score at lesion, lobe and patient levels
Measured: June 2020
AUC of the Likert score for predicting ISUP ≥2 cancer at biopsy at the lesion, lobe and patient levels
Measured: June 2020
Inter-reader concordance of the Likert score at lesion, lobe and patient levels
Measured: June 2020
Analysis of the diagnostic value of the PI-RADS v2.1 components
The PI-RADS v2.1 score is made by several components who have different diagnostic weights. The added value of the following components will be assessed:
- Lesions DCE+: do they correspond more often to ISUP ≥2 cancers than DCE- lesions?
- Lesions with DWI score of 4: is a size of 10-14 mm more predictive of ISUP ≥2 cancers than a size < 10 mm?
- Lesions with a T2w score of 2 and a DWI score of 4 in the PI-RADS v2.1 score: what is the proportion of ISUP ≥2 cancers?
Measured: June 2020
Added value of the Likert score
- This part will be only exploratory and narrative. It is aimed at evaluating, at least for the most experienced readers, if there are circumstances in which the Likert score (i.e. "gut feeling") is more predictive of ISUP ≥2 cancers than the PI-RADS v2.1 score.
Measured: June 2020
Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up
Because targeted and systematic biopsy may miss cancer foci, follow-up data will be retrieved from the patients' files. Patients with no follow-up data within the last year will be reached by phone to update their follow-up.The patients with initial biopsy showing no cancer or ISUP 1 cancer and who were subsequently diagnosed with ISUP ≥2 cancers during the 3-year follow-up will be reported and described.
Measured: June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Sep 2019
- Primary completion31 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 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
- NCT04299997
- Sponsor's protocol ID
- MULTI_2020
- Acronym
- MULTI
- Status last verified
- Feb 2022
- First submitted
- 5 Mar 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study
- ClinicalTrials.gov ID
- NCT04299997
- Acronym / sponsor ID
- MULTI / MULTI_2020
- Conditions
- Prostate Cancer, Urological Cancer
- Keywords
- multiparametric MRI, ISUP, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 9 Mar 2020 (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 interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.
The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 171 prostate MRIs using 21 readers of varying experience.
Twenty-one readers (14 seniors and 7 juniors) from 9 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.
Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 171 mpMRIs corresponding to consecutive patients who underwent | – | Other: Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.The mpMRIs were performed on a 1.5T GE MR unit or on a 3T GE or Philips MR units. All mpMRIs included T2-weighted imaging, diffusion-weighted imaging (maximal b value: 2000 s/mm²) and dynamic contrast-enhanced imaging. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with mpMRI and subsequent biopsy between September 2015 and July 2016 (see above).
Key inclusion criteria (3 listed)
- Prostate mpMRI and biopsy performed at our institution
- Performed between September 2015 and July 2016
- No history of prostate cancer at the time of the mpMRI
Key exclusion criteria (2 listed)
- Patients who already had treatment for prostate cancer
- Patients under Active Surveillance
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 |
|---|---|---|
| Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 171 MRIs for 21 different readers.1. Ass of targeted suspect lesions On each mpMRI,radiologist will contour lesions that were targeted at subsequent biopsy based on reports. Contours will be disclosed to readers who will assess,for each lesion: * Likert score("gut feeling"ie subjective ass of the likelihood that lesion is clinically significant prostate cancer(5-level scale)) * PI-RADSv2, PI-RADSv2.1 score(by strictly applying the published PI-RADS criteria) * EPE score(ie the likelihood of extraprostatic extension;5-level subjective scale without predefined criteria) * Max diameter 2. Def of add suspect lesions Readers could define suspect"additional targets"(AT);for each AT,they will provide the same criteria. It is expected that, for these suspect AT,at least one score is≥3 3. Ass of lobes Scores of prostate lobes will be automatically calculated based on 2 previous steps of reading. However,in lobes with no suspect lesion,readers could define whether same criteria are1or2,in peripheral zone and transition zone | Other | 171 mpMRIs corresponding to consecutive patients who underwent |
Primary outcome
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
Time frame: June 2020.
Analysis at the lesion level will be favored to get an evaluation of the influence of experience of readers scoring the exact same set of lesions.
9 secondary outcomes
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at biopsy, at the lesionlobe and patient levels
Time frame: June 2020
Inter-reader concordance of the PI-RADS v2.1 score, at lesion, lobe and patient levels
Time frame: June 2020
AUC of the PI-RADS v2 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion, lobe and patient levels
Time frame: June 2020
Inter-reader concordance of the PI-RADS v2 score at lesion, lobe and patient levels
Time frame: June 2020
AUC of the Likert score for predicting ISUP ≥2 cancer at biopsy at the lesion, lobe and patient levels
Time frame: June 2020
Inter-reader concordance of the Likert score at lesion, lobe and patient levels
Time frame: June 2020
Analysis of the diagnostic value of the PI-RADS v2.1 components
Time frame: June 2020
Added value of the Likert score
Time frame: June 2020
Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up
Time frame: June 2020
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 15 Mar 2022.
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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?
An observational study of Prostate Cancer and Urological 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 3 inclusion and 2 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 15 Mar 2022. 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?
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level. (time frame: June 2020.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.