Multi-omics Analysis of Prostate Derived Extracellular Vesicles: an Observational Retrospective Study for Prostate Cancer Diagnosis and Monitoring

NCT07355985 | Completed

• 1 other identifier: EXOMAP
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Prostate Cancer Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Identify a multi-omics signature from EPS-urine derived EVs in prostate cancer

  The primary objective is to identify a multi-omics signature from EPS-urine derived EVs in prostate cancer. All these analyses will be included: 1. Multi-Omics characterization of bulk EPS-urine derived EVs 2. Enrichment for prostate-specific EV subpopulations using specific markers 3. Optimization of low loads LC-MS/MS methods for analysis of prostate specific EVs To achieve the primary objective the following analysis will be performed: 1. Determination of relative abundance (peak intensities) of EV-associated proteins, lipids and metabolites measured by high-resolution LC-MS/MS 2. Determination of Purity and concentration (particles/mL) of highly specific prostate derived EVs subpopulation by NTA (nanoparticle tracking analysis) and fluorescence 3. Determination of relative abundance (peak intensities) and eventual differential pattern of Prostate-specific EVs proteins, lipids and metabolites measured by high-resolution and high throughput mass spectrometer

  Baseline / Time zero

Secondary Outcomes (1)

• Correlation between EVs multiomics profiling and prostate cancer clinical progression.

  Baseline / Time zero

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Aged \< 18 years old
• Concomitant other urological malignancies
• Previous systemic oncological treatments for prostate cancer

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: December 31, 2018
• Last Updated: January 21, 2026

Record last verified: 2026-01