NCT06807398

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 367 (actual)
• Sponsor: Francesco Montorsi · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
GENETIC	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

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-04-10
• Completion: 2024-12-31
• First posted: 2025-02-04
• Last updated: 2025-02-04

Locations

1 site across 1 country: Italy