# The Rigor and Clinical Utility of PSMA Enriched Extracellular Vesicles for Prostate Cancer Detection

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2023 · $520,290

## Abstract

Screening for prostate cancer saves lives but results in an overwhelming number of men being subjected to
unnecessary, invasive prostate biopsies, and the risk of over diagnosis and treatment of indolent cancer. Multi-
parametric MRI (mpMRI) of the prostate and molecular biomarkers are used to evaluate the risk of clinically
significant prostate cancer (csPCa) and need for biopsy, however they are limited in their accuracy for detecting
csPCa, resulting in many men still needing to undergo biopsy for fear of missing a significant tumor. This proposal
addresses an important issue in enhancing the precision of csPCa detection to reduce the burdens of prostate
cancer screening. Extracellular Vesicles (EVs) that are released into body fluids by cancer cells are promising
biomarkers for liquid biopsy since they can be extracted from blood and urine and carry molecular constituents
reflecting the parent tumor. The problem is selectively extracting EVs released from prostate cancers can be
challenging, and contribution by EVs of non-prostate origin can lessen detection and specificity. In collaboration
with the research and development team at Exosome Diagnostics, who are experts in the field of clinical-grade
EV biomarker analysis, we have developed a method to enrich for EVs expressing the Prostate Specific
Membrane Antigen (PSMA) surface protein. We have found that PSMA EV capture enrichment results in the
detection of a different, and potentially more prostate specific profile of EV mRNAs and long non-coding RNAs.
However while EV contents are well protected by lipid membranes, optimal conditions for the collection and
processing of EVs expressing PSMA surface protein have not yet been rigorously defined. In our proposed
project, we will focus on development of a urine PSMA EV assay that is more specific for csPCa than the other
currently available tests for PCa. Specifically, we will test the hypothesis that the urine EVs obtained by PSMA
enrichment can provide a panel of EV RNA markers that can substantially enhance prostate cancer risk
assessment. In Specific Aim 1, we have developed an innovative multi-factor assay development plan to address
previous limitations in the rigor and reproducibility of surface antigen capture and develop an optimal workflow
for PSMA enrichment. In Specific Aim 2, we will conduct RNAseq comprehensive profiling of PSMA enriched
and total EVs from men in an ongoing U Miami (MDSelect: NCT04240327) clinical trial enrolling 250 patients
undergoing biopsy for evaluation of csPCa to determine the additive value of PSMA enrichment over total EVs
for csPCa detection. In Specific Aim 3, we will develop and validate a novel urinary EV signature to enhance the
accuracy of csPCa detection using RNAseq data from PSMA enriched and total EVs, with multi-institutional
validation in an ongoing NCI EDRN (NCT03784924) clinical trial. Based on our preliminary data and the
combined expertise of our research team we are well positioned to ...

## Key facts

- **NIH application ID:** 10745084
- **Project number:** 1R01CA272766-01A1
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** SANDRA M GASTON
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $520,290
- **Award type:** 1
- **Project period:** 2023-07-12 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10745084

## Citation

> US National Institutes of Health, RePORTER application 10745084, The Rigor and Clinical Utility of PSMA Enriched Extracellular Vesicles for Prostate Cancer Detection (1R01CA272766-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10745084. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*