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

NCT06807398 | Completed

• 1 other identifier: RF-2018-12368399
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

Brief Summary

Radical prostatectomy (RP) represents one treatment option for clinically localized prostate cancer (PCa). The most updated guidelines of the European Association of Urology indicate the need to perform ePLND in patients with a lymph node invasion (LNI) risk \>5% according to the Briganti nomogram. This approach allows sparing ePLND in two thirds of contemporary surgically treated patients; however, many patients still receive ePLND in the absence of lymph node metastases. This is clinically relevant, since ePLND is associated with significant risks of complications. Improving the ability to detect LNI in PCa would be important for two main reasons: (1) enabling more timely treatments that may improve patient outcomes, and (2) avoiding significant overtreatment and reducing ePLND-related toxicity. The hypothesis of the present study is that lymphatic spread of PCa cells may be predicted through integration of clinical variables, radiologic findings, and epigenomic information. The objective of the study is to develop an accurate predictive model including radiological and epigenomic information.

Conditions

Prostate Cancer (Adenocarcinoma)

Outcome Measures

Primary Outcomes (1)

• All patients treated with RP + PLND will have available information from clinical data, histo-pathological data, pre-operative mp-MRI, and epigenomic analysis. These data will be used to develop a novel predictive model assessing the risk of LNI.

  2020-2024

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data collection followed the principles outlined in the Declaration of Helsinki. All enrolled patients signed an informed consent form agreeing to supply their own anonymous information and tissue specimens for this and future studies.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Francesco Montorsi: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

IRCSS San Raffaele

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Alberto Briganti, MD, PhD

  IRCSS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: June 15, 2020
• Primary Completion: April 10, 2021
• Study Completion: December 31, 2024
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)