Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer (RF-2018-123683)

Francesco Montorsi

Status: Completed

Conditions: Prostate Cancer (Adenocarcinoma)

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

Study type: Observational

Funder types: Other

Identifiers

NCT06807398

RF-2018-12368399

Details and patient eligibility

About

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.

Enrollment: 367 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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