Validation of a machine learning model for predicting prostate cancer using MRI
Validation of a Machine Learning Model Based on Multiparametric MR for the Prediction of Clinically Significant Prostate Cancer
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06773598
This study is testing a new computer tool that uses MRI scans to see if it can better predict the chances of having significant prostate cancer in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06773598 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a predictive machine learning model that analyzes multiparametric magnetic resonance imaging (mpMRI) data to assess the likelihood of clinically significant prostate cancer. The study will evaluate the model's specificity and sensitivity by analyzing both retrospective and prospective data collected from patients at the IRCCS Bologna University Hospital. Radiologists will utilize a tool developed by the University of Bologna to segment MRI images and generate predictive values for prostate lesions. The study focuses on improving diagnostic accuracy for prostate cancer detection.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with lesions classified as PI-RADSv2.1 ≥ 1 who are indicated for a TRUS biopsy.
Not a fit: Patients who have undergone previous prostate surgery or hormone therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis, leading to better patient outcomes.
How similar studies have performed: Other studies utilizing machine learning models for cancer prediction have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged 18 at the time of examination * Obtaining informed consent * Presence of one or more lesions classified as PI-RADSv2.1 ≥ 1 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna * Indication for TRUS biopsy by fusion technique integrated with systematic biopsy at the IRCCS Azienda Ospedaliero-Universitaria in Bologna Exclusion Criteria: * Previous prostate surgery or hormone therapy * Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Caterina Gaudiano, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Caterina Gaudiano, MD
- Email: caterina.gaudiano@aosp.bo.it
- Phone: +39 0515142307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Radiomics, mpMRI