Artificial Intelligence & Prostate Cancer

NCT06298305 | Completed

• 1 other identifier: QUANTIB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  12

Secondary Outcomes (2)

• To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy

  12

• To report time reduction in the diagnosis of suspicious PCa

  12

Interventions

Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

• 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.

  PMID: 40332649 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 7, 2024
• Study Start: March 8, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IT (1)