IRCSS San Raffaele
Milan, Italy, 20132
NCT Number: NCT06807398
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.
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Notify Me18 year and older
Male
Observational
Milan, Italy, 20132
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2020-2024
Francesco Montorsi
Other
Acronym: RF-2018-123683
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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