Clinical trial NCT06807398: Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
Official title: Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer (Adenocarcinoma)
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2025-02-04
Enrollment: 367
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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

Primary outcomes:
measure: 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.
timeFrame: 2020-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCSS San Raffaele
Study officials:
affiliation: IRCSS San Raffaele
name: Alberto Briganti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: