Prostate Cancer (Adenocarcinoma)RF-2018-123683NCT06807398
Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma), run by Francesco Montorsi at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Data will be used to develop a novel predictive model assessing the risk of LNI.
- How many people
- 367 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2020to 31 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Data will be used to develop a novel predictive model assessing the risk of LNI.
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data will be used to develop a novel predictive model assessing the risk of LNI.Genetic
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start15 Jun 2020
- Primary completion10 Apr 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 367 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Francesco Montorsi
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Responsible party
- Sponsor-investigator, Francesco Montorsi, IRCCS San Raffaele
- Investigators
- Alberto Briganti, MD, PhD, Principal investigator, IRCSS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807398
- Sponsor's protocol ID
- RF-2018-12368399
- Acronym
- RF-2018-123683
- Status last verified
- May 2026
- First submitted
- 29 Jan 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Signature Integrating Clinical, Imaging And Epigenetic Information to Tailor Pelvic Nodal Treatment in Prostate Cancer
- ClinicalTrials.gov ID
- NCT06807398
- Acronym / sponsor ID
- RF-2018-123683 / RF-2018-12368399
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Francesco MontorsiUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data will be used to develop a novel predictive model assessing the risk of LNI.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 | Genetic | – |
Primary outcome
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.
Time frame: 2020-2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Briganti, MD, PhD principal investigator
IRCSS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by Francesco Montorsi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2020-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.