Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions

Recruiting

• Conditions: Prostate Cancer (Adenocarcinoma)

• Registration Number: NCT06774781
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The goal of this observational study is to assess the chance to predict prostate cancer with the analysis of specific values found in images obtained from RMmp (multiparametric magnetic resonance imaging) of patients who went through the procedure at IRCCS Azienda Ospedaliero-Universitaria hospital in the city of Bologna from September 2015 to March 2021.

The main question it aims to answer is:

- does the analysis of ADC values and radiomics values found in the RMmp images help with the detection of prostate cancer?

Detailed Description

The radiologist involved in this observational study will enroll the participants, collect their informed consent and radiological data.

The urologist will collect the clinical data while the Anatomo-pathologist will take care of the hystological data.

The ADC values of the suspected lesions and healthy parenchyma will be extracted from the MR exams. For the evaluation of radiometric characteristics, images will first be de-identified, the downloaded and processed by the hospital's medical physicists.

The engineers at the University of Bologna, led by medical investigators, will extract the radiomic characteristics All data will be anonymised and collected in a database shared between the collaborating operational units.

Study Timeline

• Study Start: 2021-10-23
• Status Verified: 2024-10
• Primary Completion: 2024-12-31
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Presence of one or more lesions classified as PI-RADSv2.1 ≥ 3 at a prostate RMmp at the IRCCS Azienda Ospedaliero-Universitaria in Bologna
• Indication for eco-guided targeted biopsy by fusion technique integrated with systematic biopsy
• Indication for radical prostatectomy
• Participants aged 18 at the time of examination
• Obtaining informed consent.

Exclusion Criteria

• Impossibility of performing MRI (claustrophobic or obese participants etc.) or contraindications to the execution of MRI
• Technically sub-optimal investigations for the presence of artifacts (hip prosthesis, movement of the endorectal probe, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of ADC	From enrollment to the end of treatment at 4 years	Evaluate the distribution of ADC values of the prostatic lesions cataloged according to the criteria PI-RADSv2.1 ≥ 3, comparing it with the distribution of ADC values of the healthy glandular tissue, to define a predictive threshold value for clinically significant neoplastic lesion.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy