The goal of this observational study is to validate a clinically significant predictive machine learning model based on the processing of images RMmp (Multiparametric Magnetic Resonance Imaging). To be validated the model should be evaluated on:
* Specificity (SP): is the probability of a negative test result, conditioned on the individual truly being negative
* Sensitivity (SN): is the probability of a positive test result, conditioned on the individual truly being positive
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.)
Primary outcome measure(s)
Specificity (SP) — From enrollment to the end of treatment at 5 years Specificity is the probability of obtaining a negative classification or that the disease is indeed absent.
Sensitivity (SN) — From enrollment to the end of treatment at 5 years Sensitivity is the probability of a positive classification or that the disease is actually present.
Positive Predictive Value (PPV) — From enrollment to the end of treatment at 5 years It is the ratio of patients truly diagnosed as positive to all those who had positive test results (including healthy subjects who were incorrectly diagnosed as patient).
Negative Predictive Value (NPV) — From enrollment to the end of treatment at 5 years It is the ratio of subjects truly diagnosed as negative to all those who had negative test results (including patients who were incorrectly diagnosed as healthy).
Trial sites (1)
Facility
City
Region
Status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Italy
Recruiting
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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