NCT06807398Completed
Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 367 (actual)
- First submitted
- 29 Jan 2025
- Start date
- 15 Jun 2020
- Primary completion date
- 10 Apr 2021
- Lead sponsor
- Francesco Montorsi
- Diseases
- Prostate cancer
- NCT number
- NCT06807398
What you commit to
- Study type: Observational
- Participants enrolled: 367
- From 15 Jun 2020 to the primary completion date, 10 Apr 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCSS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.