Artificial Intelligence-based Platform, Integrating Pathologic, Imaging and Molecular Profiles of Prostate Cancer

Launched by AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITA · Jun 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to assess prostate cancer using an artificial intelligence (AI) platform. The goal is to gather and combine different types of data—like medical history, imaging results, and genetic information—to better understand which men with prostate cancer are at risk of their disease worsening and which ones might not need aggressive treatment. By improving how doctors predict cancer progression, this study aims to help patients receive the right level of care.

To participate in this trial, you need to be a man between 18 and 80 years old who has been diagnosed with prostate cancer. You must provide consent to share your medical information and allow for certain tests, including MRI scans and genetic analyses of your prostate tissue. Participants will be followed according to standard care practices, and the study involves both looking back at past patients and recruiting new ones for ongoing analysis. If you qualify, you'll be contributing to important research that could change how prostate cancer is managed in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Adults patients, aged between 18 and 80 years
• • Signed an informed consent form (ICF) indicating that the subject or his closest relative understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing to allow MRI anonymized revision and processing and biopsy/Radical Prostatectomy (RP) material genomic/transcriptomic and exploratory analyses. Moreover they must be willing to adhere to normal clinical follow-up.
• • Availability of MRI conducted prior to RP, with at least T2 weighted image (T2W), diffusion-weighted imaging (DWI), dynamic contrast-enhanced (DCE) sequences in accordance with the American College of Radiology standards for Prostate Imaging-Reporting and Data System (PI-RADS) evaluation. This criterion is not mandatory for the metastatic cohort.
• • Availability of formalin-fixed paraffin-embedded (FFPE) radical prostatectomy specimen for genomic, transcriptomic and exploratory analyses. Prostate or metastasis biopsy FFPE are acceptable for the metastatic cohort.
• • Histological diagnosis of adenocarcinoma of the prostate
• • Availability of PSA dosage and clinical evaluation of the tumor (via digital rectal exam \[DRE\]) in the 3 months preceding surgery (except for the metastatic cohort, where surgery does not apply).
• • Availability of at least one postoperative prostate specific antigen (PSA) in between 3 and 8 weeks after surgery (except for the metastatic cohort, where surgery does not apply).
• • Minimal follow-up duration of 2 years (or until death) after surgery (or after diagnosis for the metastatic patient).
• Exclusion Criteria:
• • Bilateral orchiectomy
• • Neoadjuvant hormone therapy or any prostate cancer-directed therapy before radical prostatectomy
• • History of pelvic radiation before RP.
• • Active malignancy in the last 24 months, excluding Prostate Cancer, Non-muscle-invasive Bladder Cancer (NMIBC), cured skin cancer (excluding melanoma) or other malignancies with minimal risk of recurrence.
• • Active surveillance lasting more than 12 months