Prostate CancerQUANTIBNCT06298305
Artificial Intelligence & Prostate Cancer
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will… 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?
- Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2023to 2 Sep 2024
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: A total of 200 patients who received mpMRI with endorectal coil at the Department of Radiology of the IRCCS Ospedale San Raffaele, Milan, Italy from January 2014 to January 2022 due to a clinical suspicion of PCa and subsequently underwent prostate biopsy will be retrospectively identified and will represent the study cohort.
Who may be able to join
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Men who have undergone mpMRI and subsequent targeted plus random systematic prostate biopsies
- Available pathological report with details regarding the site of positive cores and grade group
- Serum PSA ≤ 20
- Patient who underwent a 1.5T mpMRI with or without endorectal coil with the following protocol restrictions and according to recent European Guidelines, each case containing at least the following sequences, will be considered:
- T2w
Show all 15Show fewer
- No fat suppression
- At least axial acquisition
- Max voxel size 1.0x1.0x3.0mm DWI
- At least on b-value ≥800 s/mm^2 required, ≥1400 s/mm^2 preferred
- ADC map required
- Max voxel size: 2.0x2.0x4.0mm
- Axial scanning protocol only DCE scan
- Recommended temporal resolution <15s
- Axial scanning protocol only
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Artificial Intelligence in the Assessment of Multiparametric Resonance of the Prostate in Prostate Cancer Patients
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard.
Read the detailed description
An increasing number of certified software using AI in radiology is becoming available. Nonetheless, the role of AI in the detection of prostate lesions at mpMRI in men with suspicious PCa is still under debate. Specifically, it is unknown whether the use of AI may help clinicians in the decision-making process with a reliable inter-observer agreement compared to assessments done by high-volume experienced dedicated uro-radiologists. In this context, the use of digital platforms available on the market such as Quantib Prostate (Quantib B.V. Rotterdam, The Netherlands) could help in the identification of patients at higher risk of clinically significant PCa (csPCa). Among the other platforms, Quantib Prostate has a validated algorithm for the evaluation of prostate MRI which has been already tested in the clinical setting and which holds a CE mark and authorization for clinical use. Moreover, the use of Quantib Prostate may lead to advantages in terms of time reduction, time-efficiency and diagnostic performance compared with the traditional radiologist approach, with a potential impact on report quality.For these reasons, among the various AI softwares which are currently available, we decided to select Quantib Prostate for these analyses.
The potential implication of this study includes:
- Establishing inter-observer agreement between AI and traditional radiologist approach
- Time reduction in the diagnosis of suspicious PCa
- Error reduction within the imaging workflow
- Conditions
- Prostate Cancer
- Being tested
- Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) softwareDevice
Quantib Prostate is an AI-driven solution that provides an intuitive workflow for assessment of prostate MRI. The product integrates essential prostate MRI reading features into one workflow making it easy for the user to read, assess and report each patient case from within the same software interface. With automatic forwarding in place, the software preprocesses the MRI right after scanning. This allows the user to access calculations and analysis immediately when they open the software interface. Thanks to these features, the professional may experience an accelerated workflow, making it easier to manage their heavier workload.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI
Measured: 12
Secondary outcomes (2)
To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy
Measured: 12
To report time reduction in the diagnosis of suspicious PCa
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start8 Mar 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 IRCCS San RaffaeleThe 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Gandaglia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298305
- Sponsor's protocol ID
- QUANTIB
- Acronym
- QUANTIB
- Status last verified
- May 2026
- First submitted
- 20 Feb 2024
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Russo T, Quarta L, Pellegrino F, Cosenza M, Camisassa E, Lavalle S, Apostolo G, Zaurito P, Scuderi S, Barletta F, Marzorati C, Stabile A, Montorsi F, De Cobelli F, Brembilla G, Gandaglia G, Briganti A. The added value of artificial intelligence using Quantib Prostate for the detection of prostate cancer at multiparametric magnetic resonance imaging. Radiol Med. 2025 Jul;130(7):1105-1114. doi: 10.1007/s11547-025-02017-8. Epub 2025 May 7.
PubMed 40332649
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Artificial Intelligence in the Assessment of Multiparametric Resonance of the Prostate in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06298305
- Acronym / sponsor ID
- QUANTIB / QUANTIB
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 7 Mar 2024 (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.
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard.
Detailed description
An increasing number of certified software using AI in radiology is becoming available. Nonetheless, the role of AI in the detection of prostate lesions at mpMRI in men with suspicious PCa is still under debate. Specifically, it is unknown whether the use of AI may help clinicians in the decision-making process with a reliable inter-observer agreement compared to assessments done by high-volume experienced dedicated uro-radiologists. In this context, the use of digital platforms available on the market such as Quantib Prostate (Quantib B.V. Rotterdam, The Netherlands) could help in the identification of patients at higher risk of clinically significant PCa (csPCa). Among the other platforms, Quantib Prostate has a validated algorithm for the evaluation of prostate MRI which has been already tested in the clinical setting and which holds a CE mark and authorization for clinical use. Moreover, the use of Quantib Prostate may lead to advantages in terms of time reduction, time-efficiency and diagnostic performance compared with the traditional radiologist approach, with a potential impact on report quality.For these reasons, among the various AI softwares which are currently available, we decided to select Quantib Prostate for these analyses.
The potential implication of this study includes:
- Establishing inter-observer agreement between AI and traditional radiologist approach
- Time reduction in the diagnosis of suspicious PCa
- Error reduction within the imaging workflow
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- A total of 200 patients who received mpMRI with endorectal coil at the Department of Radiology of the IRCCS Ospedale San Raffaele, Milan, Italy from January 2014 to January 2022 due to a clinical suspicion of PCa and subsequently underwent prostate biopsy will be retrospectively identified and will represent the study cohort.
Key inclusion criteria (15 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Men who have undergone mpMRI and subsequent targeted plus random systematic prostate biopsies
- Available pathological report with details regarding the site of positive cores and grade group
- Serum PSA ≤ 20
- Patient who underwent a 1.5T mpMRI with or without endorectal coil with the following protocol restrictions and according to recent European Guidelines, each case containing at least the following sequences, will be considered:
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) softwareQuantib Prostate is an AI-driven solution that provides an intuitive workflow for assessment of prostate MRI. The product integrates essential prostate MRI reading features into one workflow making it easy for the user to read, assess and report each patient case from within the same software interface. With automatic forwarding in place, the software preprocesses the MRI right after scanning. This allows the user to access calculations and analysis immediately when they open the software interface. Thanks to these features, the professional may experience an accelerated workflow, making it easier to manage their heavier workload. | Device | – |
Primary outcome
To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI
Time frame: 12
2 secondary outcomes
To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy
Time frame: 12
To report time reduction in the diagnosis of suspicious PCa
Time frame: 12
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 18 May 2026.
- Derived from this study: PubMed 40332649Russo T, Quarta L, Pellegrino F, Cosenza M, Camisassa E, Lavalle S, Apostolo G, Zaurito P, Scuderi S, Barletta F, Marzorati C, Stabile A, Montorsi F, De Cobelli F, Brembilla G, Gandaglia G, Briganti A. The added value of artificial intelligence using Quantib Prostate for the detection of prostate cancer at multiparametric magnetic resonance imaging. Radiol Med. 2025 Jul;130(7):1105-1114. doi: 10.1007/s11547-025-02017-8. Epub 2025 May 7.
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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, run by IRCCS San Raffaele at 1 site in Italy.
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 15 inclusion and 1 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 18 May 2026. 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 Italy. 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?
To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI (time frame: 12). 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 NCT06298305, 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 18 May 2026.