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

CompletedOBSERVATIONAL
Enrollment

367

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

April 10, 2021

Study Completion Date

December 31, 2024

Conditions
Prostate Cancer (Adenocarcinoma)
Interventions
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

Trial Locations (1)

20132

IRCSS San Raffaele, Milan

All Listed Sponsors
collaborator

Ministero della Salute, Italy

OTHER

lead

Francesco Montorsi

OTHER

NCT06807398 - Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer | Biotech Hunter | Biotech Hunter