Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer

NCT ID: NCT06807398

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 367 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2024-12-31

Brief Summary

Radical prostatectomy (RP) represents one treatment option for clinically localized PCa. The most updated guidelines of the European Association of Urology indicate the need to perform ePLND in patients with a LNI risk >5% according to the Briganti nomogram. It allows for sparing ePLND in two thirds of contemporary surgically treated patients, but many patients still receive an ePLND in the absence of lymph node metastases. This is key, since ePLND is associated with significant risks of complications. Improving our ability to detect LNI in PCa would be key for two main reasons: 1. To administer more timely treatments which in turn improve patient outcomes. 2. To avoid significant overtreatment and spare ePLND-related toxicity. Our hypothesis is that lymphatic spread of PCa cells might be predicted through integration of clinical variables, radiologic and epigenomic information. We aim at developing an accurate predictive model that includes radiological and epigenomic information.

Conditions

Prostate Cancer (Adenocarcinoma)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Data will be used to develop a novel predictive model assessing the risk of LNI.

The epigenetic signature will be tested on DNA extracted from PCa tissue obtained at prostate biopsy. For each patient, 2 positive cores will be analysed. The 2 cores will be selected as follows: (i) one core from the index lesion; the core with the highest Gleason Score will be selected. In case of two or more cores with the same Gleason Score, the one with the highest percentage of cancer involvement will be selected; (ii) one core with the highest Gleason score outside the index lesion. In case of two or more cores with the same Gleason score, the one with the highest percentage of cancer involvement will be selected. The epigenetic signature will be tested on DNA extracted from prostate cancer tissue obtained from the two positive cores. In particular, the epigenetic score will be calculated on the prostatic tissue using the epigenetic signatures previously identified \[8\].In patients diagnosed with PCa who will be treated with RP, ePLND will be performed when the predicted LNI risk

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with localized prostate cancer (cTanyN0M0) who underwent radical prostatectomy and extended PLND
• All included patients presented one or multiple lesions at the mp-MRI of the prostate, defined as PI-RADS 3 to 5
• At least two biopsy cores were required: i) one positive core from the mp-MRI PI-RADS 3- 5 lesion/s (target lesion), ii) one positive core from the systematic sampling (outside the target lesion)

Exclusion Criteria

• Unavailable or negative mp-MRI, unavailable or negative target or systematic biopsy, and refute to undergo radical prostatectomy with PLND at the Ospedale San Raffaele

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministero della Salute, Italy

OTHER

Sponsor Role: collaborator

Francesco Montorsi

OTHER

Sponsor Role: lead

Responsible Party

Francesco Montorsi

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alberto Briganti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCSS San Raffaele

Locations

IRCSS San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

RF-2018-12368399

Identifier Type: -

Identifier Source: org_study_id