Prostate CancerRADARNCT07875491
Artificial Intelligence Software (Prostate Intelligence) for Detecting Clinically Significant Prostate Cancer on MRI
A study testing AI-based prostate MRI analysis software in people with Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are referred for MRI because prostate cancer is suspected. 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?
- AI-based prostate MRI analysis software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a prostate gland (biological males, including transgender women with a prostate gland)
- Age 18 years or older
- Referred for prostate MRI for suspected prostate cancer
- Signed informed consent and consent to personal data processing
Who cannot join
- Previous prostate biopsy
- Previous treatment for prostate cancer or benign prostatic hyperplasia
- Any factor that may compromise MRI scan quality (e.g. metal implants, UroLift)
- Contraindications to MRI
- Contraindications to prostate biopsy
- Failure to sign informed consent and/or consent to personal data processing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Luca Russo, MD, PhD, +39 06 30156054, luca.russo@policlinicogemelli.it
Luca Russo, MD, PhD
About this study
Official title: A Prospective, Multi-Centre Diagnostic Accuracy Study of AI-based Prostate Cancer Diagnosis Software
The goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are referred for MRI because prostate cancer is suspected.
The main question it aims to answer is:
Read more
- How sensitive and specific is Pi, used on its own, in detecting clinically significant prostate cancer (Gleason grade 3+4 or higher) at the patient level?
Researchers will also compare Pi, the radiologist alone, and the radiologist assisted by Pi, to see whether AI assistance changes cancer detection.
Participants will:
- Undergo prostate MRI as part of their usual clinical care. Each MRI is first read by a radiologist without the AI result; the Pi report is then shown to the radiologist, who produces a final combined report.
- Undergo targeted prostate biopsy (up to two lesions) if the MRI is suspicious, as in routine practice. Areas flagged only by Pi may also be biopsied.
- If not biopsied, be followed for 12 months after MRI with PSA tests at 6 and 12 months and clinical assessment, to confirm the absence of clinically significant cancer.
About 226 participants will be enrolled at two Italian centres (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, and IRCCS Ospedale San Raffaele, Milan).
Read the detailed description
Background and rationale Prostate cancer is the most common cancer in men in Europe. International guidelines recommend multiparametric MRI before biopsy, and findings are graded with PI-RADS v2.1. PI-RADS assessment varies with institution, reader experience and field strength, and inter-reader variability is substantial among less experienced radiologists. Prostate Intelligence (Pi, Lucida Medical Ltd) is an AI software that analyses prostate MRI and provides prostate volume, lesion detection/segmentation, an AI-Likert score and a preliminary report as a concurrent read to support the radiologist. This study evaluates the diagnostic performance of Pi in a prospective clinical setting.
Design Prospective, multicentre (national), interventional diagnostic accuracy study with a medical device. The software runs on servers of the participating institutions; DICOM data are de-identified and imaging data do not leave the institutional perimeter.
Reading workflow For each examination the radiologist first reports the MRI blinded to Pi; the report is locked and time-stamped in RIS/PACS. The Pi output is then made available and the radiologist produces a merged Pi-assisted report, recording PI-RADS v2.1 categories, lesion zone and whether each Pi finding is accepted or rejected, and adding any lesions considered missed by Pi.
Reference standard Histopathology from MRI-targeted biopsy (maximum two lesions, including discordant radiologist/Pi lesions) and, where available, radical prostatectomy. Participants who are not biopsied are followed for 12 months after MRI (PSA at 6 and 12 months plus clinical assessment) and classified as composite true negatives when there is no evidence of clinically significant cancer. Clinically significant prostate cancer (csPCa) is defined as Gleason grade 3+4 or higher.
Endpoints Co-primary: patient-level sensitivity and specificity of stand-alone Pi for csPCa (Gleason >=3+4).
Secondary (all exploratory): diagnostic performance of the Pi-assisted read at patient level for Gleason >=3+4 and >=4+3; comparison of Pi-assisted vs radiologist-alone and Pi vs radiologist-alone; proportion of csPCa detected and additional csPCa detection with Pi; lesion-level performance of the Pi-assisted read; exploratory cost-consequence analysis; subgroup performance in patients with radical prostatectomy histology.
Sample size 226 participants (150 at Gemelli, 76 at San Raffaele), based on 7.5% precision at a 5% significance level for an expected Pi sensitivity of 90% and specificity of 65%, with an assumed csPCa prevalence of 31% (R v4.4.2). Assumptions are conservative relative to published validation of the device. The study is powered for stand-alone accuracy only; comparative endpoints are exploratory.
Statistical analysis Sensitivity, specificity, PPV, NPV and ROC AUC with 95% CIs. AUCs of radiologist-alone, Pi-alone and Pi-assisted reads compared with the DeLong method, with bootstrapped two-sided 95% CIs. Lesion-level metrics (PI-RADS >=3 as positive) use generalised estimating equations to account for clustering. The primary analysis includes histologically verified participants and composite true negatives; pre-specified sensitivity analyses are restricted to histologically verified participants and a bounding analysis assigning unverified participants first to non-csPCa and then to csPCa. Missing data are tabulated and the primary analysis uses complete cases. Exploratory comparative p-values are reported unadjusted and Benjamini-Hochberg adjusted (5%). Centre, scanner model and field strength are recorded and explored as subgroups; no centre contributes more than 70% of participants. Reporting follows STARD.
Duration 27 months: 12 months enrolment and data collection, up to 12 months follow-up per participant, 3 months analysis.
Safety All adverse events are recorded; device incidents and deficiencies are reported to the National Competent Authority and the manufacturer under EU Regulation 2017/745 and Italian Legislative Decree 137/2022.
- Conditions
- Prostate Cancer
- Being tested
- AI-based prostate MRI analysis software
- Keywords
- prostate cancer, magnetic resonance imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based prostate MRI analysis softwareDevice
Also called Prostate Intelligence (Pi)
Prostate Intelligence (Pi, Lucida Medical Ltd) is an artificial intelligence software that analyses prostate MRI and provides prostate volume, lesion detection and segmentation, an AI-Likert score and a preliminary report. It runs on the participating institutions' servers on de-identified DICOM data. Each MRI is first reported by the radiologist blinded to Pi (report locked and time-stamped); Pi output is then revealed and the radiologist issues a merged Pi-assisted report (PI-RADS v2.1), accepting or rejecting each Pi finding. Up to two lesions per participant (radiologist- and/or Pi-identified) undergo MRI-targeted biopsy, with sampling order randomised 1:1. Non-biopsied participants are followed for 12 months (PSA at 6 and 12 months, clinical assessment).
| Study group | Role | What they receive |
|---|---|---|
| Pi-assisted prostate MRI reading | Experimental | Adults with a prostate gland referred for MRI for suspected prostate cancer. Each MRI is assessed by the radiologist alone (blinded to Pi), by Pi stand-alone, and by the radiologist assisted by Pi. Participants with suspicious lesions undergo MRI-targeted biopsy of up to two lesions (radiologist- and/or Pi-identified), with the order of lesion sampling randomised 1:1. Participants not biopsied are followed for 12 months after MRI with PSA at 6 and 12 months and clinical assessment. Receives: Device: AI-based prostate MRI analysis software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level sensitivity of Pi stand-alone for clinically significant prostate cancer (Gleason score >=3+4)
Proportion of participants with clinically significant prostate cancer (csPCa, Gleason score >=3+4 / ISUP grade group >=2) correctly identified as positive by Prostate Intelligence (Pi) stand-alone at a threshold fixed before study start. Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Reported with 95% confidence interval; NPV, PPV and ROC AUC also reported.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Patient-level specificity of Pi stand-alone for clinically significant prostate cancer (Gleason score >=3+4)
Proportion of participants without clinically significant prostate cancer (csPCa, Gleason score >=3+4 / ISUP grade group >=2) correctly identified as negative by Prostate Intelligence (Pi) stand-alone at a threshold fixed before study start. Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Reported with 95% confidence interval.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Secondary outcomes (7)
Patient-level sensitivity and specificity of the Pi-assisted radiologist read for csPCa (Gleason score >=3+4)
Sensitivity and specificity of the radiologist's merged report after review of the Pi output, for csPCa defined as Gleason score >=3+4. Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Patient-level sensitivity and specificity of the Pi-assisted radiologist read for Gleason score >=4+3 cancer
Sensitivity and specificity of the Pi-assisted read for prostate cancer of Gleason score >=4+3 (ISUP grade group >=3). Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Diagnostic performance of Pi-assisted read versus radiologist-alone read (ROC AUC)
Difference in patient-level area under the ROC curve between the Pi-assisted read and the radiologist-alone read (blinded to Pi), for csPCa (Gleason score >=3+4). Compared with the DeLong method; two-sided 95% CIs by bootstrapping. Sensitivity, specificity, PPV and NPV also compared. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Diagnostic performance of Pi stand-alone versus radiologist-alone read (ROC AUC)
Difference in patient-level area under the ROC curve between Pi stand-alone and the radiologist-alone read for csPCa (Gleason score >=3+4). Compared with the DeLong method; two-sided 95% CIs by bootstrapping. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Proportion of csPCa detected by Pi-assisted and Pi stand-alone reads versus radiologist-alone read
Proportion of participants with csPCa (Gleason score >=3+4) detected by the Pi-assisted read and by Pi stand-alone, compared with the proportion detected by the radiologist-alone read. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Lesion-level sensitivity and positive predictive value of the Pi-assisted read for csPCa
Lesion-level sensitivity and PPV of the Pi-assisted read for csPCa (Gleason score >=3+4), with PI-RADS >=3 considered positive; lesions matched to histopathology. Generalised estimating equations account for clustering of multiple lesions within a participant. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Additional csPCa detected with Pi compared with radiologist-alone read
Number and proportion of csPCa (Gleason score >=3+4) lesions/participants detected only through Pi (Pi-identified lesions not reported by the radiologist alone) and confirmed on histopathology. Exploratory.
Measured: Index test at baseline MRI; reference standard up to 12 months after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, paired-read diagnostic accuracy design. Every participant's MRI is read sequentially: (1) radiologist alone, blinded to Pi, report locked and time-stamped; (2) Pi stand-alone; (3) Pi-assisted radiologist read. All three index tests are compared against the same reference standard (MRI-targeted biopsy histopathology, radical prostatectomy where available, or 12-month clinical/PSA follow-up for non-biopsied participants). In participants with lesions to biopsy (maximum two), the order of sampling (Pi-identified lesions first vs radiologist-alone-identified lesions first) is block-randomised 1:1 using the Pi software UI; this randomises procedural order only and does not allocate participants to different interventions.
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Russo, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875491
- Sponsor's protocol ID
- 27164
- Acronym
- RADAR
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers. Under the approved consent to data processing, personal data may be communicated only between the participating centres where necessary to conduct the study, and will not be disseminated except in anonymous and/or aggregate form. Imaging data are de-identified and processed on institutional servers. Aggregate results will be published in peer-reviewed journals according to STARD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre Diagnostic Accuracy Study of AI-based Prostate Cancer Diagnosis Software
- ClinicalTrials.gov ID
- NCT07875491
- Acronym / sponsor ID
- RADAR / 27164
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (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 goal of this study is to learn how accurately an artificial intelligence (AI) software called Prostate Intelligence (Pi) detects clinically significant prostate cancer on prostate MRI in adults with a prostate gland who are referred for MRI because prostate cancer is suspected.
The main question it aims to answer is:
- How sensitive and specific is Pi, used on its own, in detecting clinically significant prostate cancer (Gleason grade 3+4 or higher) at the patient level?
Researchers will also compare Pi, the radiologist alone, and the radiologist assisted by Pi, to see whether AI assistance changes cancer detection.
Participants will:
- Undergo prostate MRI as part of their usual clinical care. Each MRI is first read by a radiologist without the AI result; the Pi report is then shown to the radiologist, who produces a final combined report.
- Undergo targeted prostate biopsy (up to two lesions) if the MRI is suspicious, as in routine practice. Areas flagged only by Pi may also be biopsied.
- If not biopsied, be followed for 12 months after MRI with PSA tests at 6 and 12 months and clinical assessment, to confirm the absence of clinically significant cancer.
About 226 participants will be enrolled at two Italian centres (Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, and IRCCS Ospedale San Raffaele, Milan).
Detailed description
Background and rationale Prostate cancer is the most common cancer in men in Europe. International guidelines recommend multiparametric MRI before biopsy, and findings are graded with PI-RADS v2.1. PI-RADS assessment varies with institution, reader experience and field strength, and inter-reader variability is substantial among less experienced radiologists. Prostate Intelligence (Pi, Lucida Medical Ltd) is an AI software that analyses prostate MRI and provides prostate volume, lesion detection/segmentation, an AI-Likert score and a preliminary report as a concurrent read to support the radiologist. This study evaluates the diagnostic performance of Pi in a prospective clinical setting.
Design Prospective, multicentre (national), interventional diagnostic accuracy study with a medical device. The software runs on servers of the participating institutions; DICOM data are de-identified and imaging data do not leave the institutional perimeter.
Reading workflow For each examination the radiologist first reports the MRI blinded to Pi; the report is locked and time-stamped in RIS/PACS. The Pi output is then made available and the radiologist produces a merged Pi-assisted report, recording PI-RADS v2.1 categories, lesion zone and whether each Pi finding is accepted or rejected, and adding any lesions considered missed by Pi.
Reference standard Histopathology from MRI-targeted biopsy (maximum two lesions, including discordant radiologist/Pi lesions) and, where available, radical prostatectomy. Participants who are not biopsied are followed for 12 months after MRI (PSA at 6 and 12 months plus clinical assessment) and classified as composite true negatives when there is no evidence of clinically significant cancer. Clinically significant prostate cancer (csPCa) is defined as Gleason grade 3+4 or higher.
Endpoints Co-primary: patient-level sensitivity and specificity of stand-alone Pi for csPCa (Gleason >=3+4).
Secondary (all exploratory): diagnostic performance of the Pi-assisted read at patient level for Gleason >=3+4 and >=4+3; comparison of Pi-assisted vs radiologist-alone and Pi vs radiologist-alone; proportion of csPCa detected and additional csPCa detection with Pi; lesion-level performance of the Pi-assisted read; exploratory cost-consequence analysis; subgroup performance in patients with radical prostatectomy histology.
Sample size 226 participants (150 at Gemelli, 76 at San Raffaele), based on 7.5% precision at a 5% significance level for an expected Pi sensitivity of 90% and specificity of 65%, with an assumed csPCa prevalence of 31% (R v4.4.2). Assumptions are conservative relative to published validation of the device. The study is powered for stand-alone accuracy only; comparative endpoints are exploratory.
Statistical analysis Sensitivity, specificity, PPV, NPV and ROC AUC with 95% CIs. AUCs of radiologist-alone, Pi-alone and Pi-assisted reads compared with the DeLong method, with bootstrapped two-sided 95% CIs. Lesion-level metrics (PI-RADS >=3 as positive) use generalised estimating equations to account for clustering. The primary analysis includes histologically verified participants and composite true negatives; pre-specified sensitivity analyses are restricted to histologically verified participants and a bounding analysis assigning unverified participants first to non-csPCa and then to csPCa. Missing data are tabulated and the primary analysis uses complete cases. Exploratory comparative p-values are reported unadjusted and Benjamini-Hochberg adjusted (5%). Centre, scanner model and field strength are recorded and explored as subgroups; no centre contributes more than 70% of participants. Reporting follows STARD.
Duration 27 months: 12 months enrolment and data collection, up to 12 months follow-up per participant, 3 months analysis.
Safety All adverse events are recorded; device incidents and deficiencies are reported to the National Competent Authority and the manufacturer under EU Regulation 2017/745 and Italian Legislative Decree 137/2022.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, paired-read diagnostic accuracy design. Every participant's MRI is read sequentially: (1) radiologist alone, blinded to Pi, report locked and time-stamped; (2) Pi stand-alone; (3) Pi-assisted radiologist read. All three index tests are compared against the same reference standard (MRI-targeted biopsy histopathology, radical prostatectomy where available, or 12-month clinical/PSA follow-up for non-biopsied participants). In participants with lesions to biopsy (maximum two), the order of sampling (Pi-identified lesions first vs radiologist-alone-identified lesions first) is block-randomised 1:1 using the Pi software UI; this randomises procedural order only and does not allocate participants to different interventions.
| Arm | Type | Receives |
|---|---|---|
| Pi-assisted prostate MRI reading | Experimental | Device: AI-based prostate MRI analysis softwareAdults with a prostate gland referred for MRI for suspected prostate cancer. Each MRI is assessed by the radiologist alone (blinded to Pi), by Pi stand-alone, and by the radiologist assisted by Pi. Participants with suspicious lesions undergo MRI-targeted biopsy of up to two lesions (radiologist- and/or Pi-identified), with the order of lesion sampling randomised 1:1. Participants not biopsied are followed for 12 months after MRI with PSA at 6 and 12 months and clinical assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with a prostate gland (biological males, including transgender women with a prostate gland)
- Age 18 years or older
- Referred for prostate MRI for suspected prostate cancer
- Signed informed consent and consent to personal data processing
Key exclusion criteria (6 listed)
- Previous prostate biopsy
- Previous treatment for prostate cancer or benign prostatic hyperplasia
- Any factor that may compromise MRI scan quality (e.g. metal implants, UroLift)
- Contraindications to MRI
- Contraindications to prostate biopsy
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 |
|---|---|---|
| AI-based prostate MRI analysis softwareAlso: Prostate Intelligence (Pi)Prostate Intelligence (Pi, Lucida Medical Ltd) is an artificial intelligence software that analyses prostate MRI and provides prostate volume, lesion detection and segmentation, an AI-Likert score and a preliminary report. It runs on the participating institutions' servers on de-identified DICOM data. Each MRI is first reported by the radiologist blinded to Pi (report locked and time-stamped); Pi output is then revealed and the radiologist issues a merged Pi-assisted report (PI-RADS v2.1), accepting or rejecting each Pi finding. Up to two lesions per participant (radiologist- and/or Pi-identified) undergo MRI-targeted biopsy, with sampling order randomised 1:1. Non-biopsied participants are followed for 12 months (PSA at 6 and 12 months, clinical assessment). | Device | Pi-assisted prostate MRI reading |
Primary outcome
Patient-level sensitivity of Pi stand-alone for clinically significant prostate cancer (Gleason score >=3+4)
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Proportion of participants with clinically significant prostate cancer (csPCa, Gleason score >=3+4 / ISUP grade group >=2) correctly identified as positive by Prostate Intelligence (Pi) stand-alone at a threshold fixed before study start. Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Reported with 95% confidence interval; NPV, PPV and ROC AUC also reported.
Patient-level specificity of Pi stand-alone for clinically significant prostate cancer (Gleason score >=3+4)
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Proportion of participants without clinically significant prostate cancer (csPCa, Gleason score >=3+4 / ISUP grade group >=2) correctly identified as negative by Prostate Intelligence (Pi) stand-alone at a threshold fixed before study start. Reference standard: histopathology from MRI-targeted biopsy or radical prostatectomy, or composite true negative status (no csPCa on 12-month clinical and PSA follow-up) for non-biopsied participants. Reported with 95% confidence interval.
7 secondary outcomes
Patient-level sensitivity and specificity of the Pi-assisted radiologist read for csPCa (Gleason score >=3+4)
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Patient-level sensitivity and specificity of the Pi-assisted radiologist read for Gleason score >=4+3 cancer
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Diagnostic performance of Pi-assisted read versus radiologist-alone read (ROC AUC)
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Diagnostic performance of Pi stand-alone versus radiologist-alone read (ROC AUC)
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Proportion of csPCa detected by Pi-assisted and Pi stand-alone reads versus radiologist-alone read
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Lesion-level sensitivity and positive predictive value of the Pi-assisted read for csPCa
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Additional csPCa detected with Pi compared with radiologist-alone read
Time frame: Index test at baseline MRI; reference standard up to 12 months after MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers. Under the approved consent to data processing, personal data may be communicated only between the participating centres where necessary to conduct the study, and will not be disseminated except in anonymous and/or aggregate form. Imaging data are de-identified and processed on institutional servers. Aggregate results will be published in peer-reviewed journals according to STARD.
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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.
Luca Russo, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based prostate MRI analysis software in people with Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Russo, MD, PhD (+39 06 30156054, luca.russo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-level sensitivity of Pi stand-alone for clinically significant prostate cancer (Gleason score >=3+4) (time frame: Index test at baseline MRI; reference standard up to 12 months after MRI). The study lists 2 primary outcomes in all. 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 Oct 2026.