NCT06807398|Completed
Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
RF-2018-123683
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RF-2018-123683
Sponsor study identifier
observational
367
1 country
1
Study Start
June 15, 2020
Actual (reported)Primary Completion
April 10, 2021
Actual (reported)Study Completion
December 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2020
Actual (reported)April 10, 2021
Actual (reported)December 31, 2024
Actual (reported)January 29, 2025
Actual (reported)February 4, 2025
Actual (reported)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
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
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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.
IRCSS San Raffaele
Milan, Italy, 20132, Italy
Alberto Briganti, MD, PhD
IRCSS San Raffaele
367 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
June 15, 2020
Actual (reported)18F-DCFPyL PET-CT Scan and Prostate Cancer
Contact the study team to confirm eligibility.
Primary Completion
April 10, 2021
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
May 15, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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