Assessment of ADC Values and Radiomics Characteristics With a MRI of the Prostate to Identify Tumor Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Adenocarcinoma). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Distribution of ADC Values and Radiometric Characteristics of Suspect Areas With a Multiparametric MRI of the Prostate to Identify Clinically Significant Neoplastic Lesions
Overview
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.
Primary outcome measures
- Distribution of ADC [Time frame: From enrollment to the end of treatment at 4 years]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06774781 · PROSTATE_01_2021