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

NCT06774781 | Recruiting

• 1 other identifier: PROSTATE_01_2021
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

Radiomics; mpMRI

Outcome Measures

Primary Outcomes (1)

• Distribution of ADC

  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.

  From enrollment to the end of treatment at 4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all participants who have performed a fusion biopsy with RMmp of the prostate in the period between the beginning of use of this technique (September 2015) and March 2021 whose images are available on RIS-PACS of the IRCCS University Hospital of Bologna will be included in the study . The sample size considered sufficient is 120 patients, of which 90 will be used for method development and 30 will be used as validation group. The latter will be used to evaluate how generalizable the results of the study are to the population, to avoid overestimating the model's capabilities in evaluating it on the same patients on which it was developed.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Caterina Gaudiano, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caterina Gaudiano, MD

CONTACT

+39 0515142307; caterina.gaudiano@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: October 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)