Using AI to improve risk assessment in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to utilize an artificial intelligence-based platform that integrates clinical, pathologic, imaging, genomic, and transcriptomic profiles of prostate cancer. The goal is to enhance the accuracy of risk stratification tools currently available, thereby improving the identification of patients at risk for disease progression. A retrospective cohort of 200 patients who underwent radical prostatectomy will be analyzed across three clinical centers. The study focuses on distinguishing between patients with indolent disease and those likely to progress to clinically significant cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• AOU Maggiore della Carità, Urology Division
  Novara, Italy Recruiting

Study contacts

• Principal investigator: Carlotta Palumbo, MD — University of Piemonte Orientale
• Study coordinator: Carlotta Palumbo, MD
• Email: carlotta.palumbo@uniupo.it
• Phone: +393491289501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.