Prostate Cancer AdenocarcinomaEXOMAPNCT07355985
Multi-omics Analysis of Prostate Derived Extracellular Vesicles: an Observational Retrospective Study for Prostate Cancer Diagnosis and Monitoring
An observational study of Prostate Cancer Adenocarcinoma, run by IRCCS San Raffaele.
Trial summary
Prostate cancer (PCa) is the most commonly diagnosed malignancy in men and a leading cause of cancer-related mortality worldwide. Over 1.4 million new cases of prostate cancer are estimated to occur worldwide each year, with more than 375,000 related deaths. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Adenocarcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- 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: 100 patients who received diagnosis of PCa or BPH through prostate biopsies between 2016 and 2018. EPS-urine samples were collected from all patients.
Who may be able to join
- Patients who received diagnosis of PCa or BPH through prostate biopsies between 2016 and 2018 and subsequently have signed the informed consent (URBBAN protocol "Regulation for the collection, storage and use of human biological material" v.4 of 14/02/2014 or v.5 of 10/04/2017)
- EPS-urine samples collected from patients undergoing prostate biopsies
- Aged > 18 years old
Who cannot join
- Aged < 18 years old
- Concomitant other urological malignancies
- Previous systemic oncological treatments for prostate cancer
About this study
Prostate cancer (PCa) is the most commonly diagnosed malignancy in men and a leading cause of cancer-related mortality worldwide. Over 1.4 million new cases of prostate cancer are estimated to occur worldwide each year, with more than 375,000 related deaths. High-risk PCa poses significant challenges due to the aggressive nature of the disease and the ability to create an immunosuppressive tumor microenvironment (TME), thereby hampering the effectiveness of existing therapies. Despite advances in diagnostics and treatment, the mechanisms driving immune evasion and tumor progression in high-risk PCa remain poorly understood. These considerations underscore the urgent need for innovative strategies to address these challenges and improve patient outcomes.
Extracellular vesicles (EVs) have emerged as critical players in cancer biology. EVs carry molecular cargo, including proteins, RNA, lipids, and metabolites, enabling mediation of intercellular communication and influence on cancer progression. Tumor-derived EVs (TDEVs) are particularly implicated in promoting tumor growth, reprogramming the TME, and suppressing antitumor immune responses. Owing to the intrinsic ability to mediate intercellular communication and transport biomolecules to distant sites, EVs represent key contributors to cancer pathogenesis.
Read more
A previous study demonstrated, through comprehensive metabolomics profiling, a combination of small molecules extracted from expressed prostatic secretion (EPS)-urine, integrated with clinical parameters, that could effectively identify and stratify PCa patients, highlighting the potential of this biofluid in PCa diagnostics. EPS-urine represents a unique biofluid enriched with EVs secreted directly by prostate tissue, offering a valuable source for the study of prostate-specific EVs. Based on this evidence, the potential of prostate cancer (PCa)-derived EVs is being explored as a transformative approach for the management of high-risk prostate cancer.
The project qualifies as a basic research study with potential translational relevance. An observational retrospective study has been designed with the objective of comprehensively characterizing extracellular vesicles (EVs) derived from EPS-urine using multi-omics approaches. The analysis will be conducted on samples from 100 patients, all recruited exclusively at the Department of Urology at IRCCS San Raffaele Hospital. Patients are categorized into two groups: patients with clinically significant prostate cancer (csPCa), including intermediate-risk PCa (ISUP grade 2-3) and high-risk PCa (ISUP grade 4-5), and patients with non-clinically significant PCa (non-csPCa), including low-risk PCa (ISUP grade 1) and patients with benign prostatic hypertrophy. The study is expected to provide unprecedented insights into prostate tissue-derived EVs, laying the foundation for functional validation of key molecular markers and pathways implicated in PCa progression.
- Conditions
- Prostate Cancer Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a multi-omics signature from EPS-urine derived EVs in prostate cancer
- Identification of a multi-omics signature from EPS-urine-derived extracellular vesicles (EVs) in prostate cancer patients, defined through integrated LC-MS/MS analysis of EV-associated proteins (relative peak intensities).
- Identification of a multi-omics lipid signature in EPS-urine-derived EVs, defined as relative abundance (peak intensities) of EV-associated lipids measured by LC-MS/MS.
- Identification of a multi-omics metabolite signature in EPS-urine-derived EVs, defined as relative abundance (peak intensities) of EV-associated metabolites measured by LC-MS/MS.
- EV concentration and size distribution in EPS-urine, measured as particles/mL and particle size distribution by nanoparticle tracking analysis (NTA).
- Prostate-specific EV enrichment, assessed using fluorescence-based quantification and specific markers.
Measured: Baseline / Time zero
Secondary outcomes (1)
Correlation between EVs multiomics profiling and prostate cancer clinical progression.
The secondary objective is to evaluate if there is a correlation between EVs multiomics profiling and prostate cancer clinical progression.
To determine this correlation, the patients will be divided in two groups:
- clinically significant prostate cancer (csPCa), including intermediate-risk PCa (ISUP grade 2-3) and high-risk PCa (ISUP grade 4-5)
- non-clinically significant PCa (non-csPCa): including low-risk PCs (ISUP grade 1) and patients with benign prostatic hypertrophy.
Samples will be characterized by multi-comics approaches in LC-MS/MS. The data collected from the two groups will be compared and evaluated using t-test statistical method. Based on the results obtained in this first phase of the study, the next step will be the validation of a predictive model using EVs multi-omics profile and patients' clinical data along with imaging data, through artificial intelligence (AI). This second part will be the object of a future study on an independent cohort of patients.
Measured: Baseline / Time zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2016
- Primary completion1 Feb 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Alberto Briganti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355985
- Sponsor's protocol ID
- EXOMAP
- Acronym
- EXOMAP
- Status last verified
- May 2026
- First submitted
- 10 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Multi-omics Analysis of Prostate Derived Extracellular Vesicles: an Observational Retrospective Study for Prostate Cancer Diagnosis and Monitoring
- ClinicalTrials.gov ID
- NCT07355985
- Acronym / sponsor ID
- EXOMAP / EXOMAP
- Conditions
- Prostate Cancer Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Jan 2026 (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.
Prostate cancer (PCa) is the most commonly diagnosed malignancy in men and a leading cause of cancer-related mortality worldwide. Over 1.4 million new cases of prostate cancer are estimated to occur worldwide each year, with more than 375,000 related deaths. High-risk PCa poses significant challenges due to the aggressive nature of the disease and the ability to create an immunosuppressive tumor microenvironment (TME), thereby hampering the effectiveness of existing therapies. Despite advances in diagnostics and treatment, the mechanisms driving immune evasion and tumor progression in high-risk PCa remain poorly understood. These considerations underscore the urgent need for innovative strategies to address these challenges and improve patient outcomes.
Extracellular vesicles (EVs) have emerged as critical players in cancer biology. EVs carry molecular cargo, including proteins, RNA, lipids, and metabolites, enabling mediation of intercellular communication and influence on cancer progression. Tumor-derived EVs (TDEVs) are particularly implicated in promoting tumor growth, reprogramming the TME, and suppressing antitumor immune responses. Owing to the intrinsic ability to mediate intercellular communication and transport biomolecules to distant sites, EVs represent key contributors to cancer pathogenesis.
A previous study demonstrated, through comprehensive metabolomics profiling, a combination of small molecules extracted from expressed prostatic secretion (EPS)-urine, integrated with clinical parameters, that could effectively identify and stratify PCa patients, highlighting the potential of this biofluid in PCa diagnostics. EPS-urine represents a unique biofluid enriched with EVs secreted directly by prostate tissue, offering a valuable source for the study of prostate-specific EVs. Based on this evidence, the potential of prostate cancer (PCa)-derived EVs is being explored as a transformative approach for the management of high-risk prostate cancer.
The project qualifies as a basic research study with potential translational relevance. An observational retrospective study has been designed with the objective of comprehensively characterizing extracellular vesicles (EVs) derived from EPS-urine using multi-omics approaches. The analysis will be conducted on samples from 100 patients, all recruited exclusively at the Department of Urology at IRCCS San Raffaele Hospital. Patients are categorized into two groups: patients with clinically significant prostate cancer (csPCa), including intermediate-risk PCa (ISUP grade 2-3) and high-risk PCa (ISUP grade 4-5), and patients with non-clinically significant PCa (non-csPCa), including low-risk PCa (ISUP grade 1) and patients with benign prostatic hypertrophy. The study is expected to provide unprecedented insights into prostate tissue-derived EVs, laying the foundation for functional validation of key molecular markers and pathways implicated in PCa progression.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients who received diagnosis of PCa or BPH through prostate biopsies between 2016 and 2018. EPS-urine samples were collected from all patients.
Key inclusion criteria (3 listed)
- Patients who received diagnosis of PCa or BPH through prostate biopsies between 2016 and 2018 and subsequently have signed the informed consent (URBBAN protocol "Regulation for the collection, storage and use of human biological material" v.4 of 14/02/2014 or v.5 of 10/04/2017)
- EPS-urine samples collected from patients undergoing prostate biopsies
- Aged > 18 years old
Key exclusion criteria (3 listed)
- Aged < 18 years old
- Concomitant other urological malignancies
- Previous systemic oncological treatments for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify a multi-omics signature from EPS-urine derived EVs in prostate cancer
Time frame: Baseline / Time zero
1. Identification of a multi-omics signature from EPS-urine-derived extracellular vesicles (EVs) in prostate cancer patients, defined through integrated LC-MS/MS analysis of EV-associated proteins (relative peak intensities). 2. Identification of a multi-omics lipid signature in EPS-urine-derived EVs, defined as relative abundance (peak intensities) of EV-associated lipids measured by LC-MS/MS. 3. Identification of a multi-omics metabolite signature in EPS-urine-derived EVs, defined as relative abundance (peak intensities) of EV-associated metabolites measured by LC-MS/MS. 4. EV concentration and size distribution in EPS-urine, measured as particles/mL and particle size distribution by nanoparticle tracking analysis (NTA). 5. Prostate-specific EV enrichment, assessed using fluorescence-based quantification and specific markers.
1 secondary outcome
Correlation between EVs multiomics profiling and prostate cancer clinical progression.
Time frame: Baseline / Time zero
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Adenocarcinoma, run by IRCCS San Raffaele.
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 3 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.
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?
Identify a multi-omics signature from EPS-urine derived EVs in prostate cancer (time frame: Baseline / Time zero). 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.