# Development of Protein Biomarkers in Post-DRE Urine for use in Liquid Biopsy of Prostate Cancer

> **NIH NIH U01** · EASTERN VIRGINIA MEDICAL SCHOOL · 2020 · $433,053

## Abstract

Prostate cancer (PCa) remains the most common non-skin malignancy afflicting men in the
United states. It is the second leading cause of cancer-related death. The clinical diversity of
PCa is dramatic, ranging from asymptomatic disease to metastatic and fatal malignancy. One
cause of this clinical diversity is the remarkable intra- and inter-tumoural heterogeneity in
disease genomics. As a result, currently clinically-used risk-stratification strategies do not
robustly discriminate aggressive from indolent diseases, leading to systemic over- and under-
treatment. Approximately 40% of men diagnosed with PCa who seek curative treatment
undergo surgical removal of their prostate (radical prostatectomy, RP). Of these, approximately
30% are found at surgery to have disease outside their prostate (non-organ-confined, non-OC).
These men are candidates for multi-modal adjuvant treatment with chemo- and hormone-
therapy to improve outcomes. We therefore propose to tackle this problem, using fluid
biomarkers to circumvent the molecular heterogeneity of the disease. Our proposal leverages
an active and productive multi-investigator, multi-institutional proteomic collaboration to develop
biomarkers for the early detection of locally aggressive non-organ-confined disease. Our two
lead biomarkers are 1) A multiple peptide panel that discriminates OC from non-OC in EDRN
phase 2 equivalent validation (Nature Communications, in press). 2) Surface expression of CUB
Domain Containing Protein 1 on exosomes differentiates PCa aggressiveness (EDRN Phase 1
equivalent discovery, Oncotarget, 2016). We propose both validation of these targets in a
globally-unique biobank of expressed prostatic secretions, as well as novel biomarker
discovery/development strategies to extend them in the same clinical context and sample
matrix. Successful completion of our proposed studies will result in validation of at least two
biomarkers for clinical utility in separation of OC vs. non-OC disease, helping to personalize
therapy for a tumour type that afflicts 1 in 7 North American men.

## Key facts

- **NIH application ID:** 10004588
- **Project number:** 5U01CA214194-05
- **Recipient organization:** EASTERN VIRGINIA MEDICAL SCHOOL
- **Principal Investigator:** Paul Christopher Boutros
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $433,053
- **Award type:** 5
- **Project period:** 2016-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004588

## Citation

> US National Institutes of Health, RePORTER application 10004588, Development of Protein Biomarkers in Post-DRE Urine for use in Liquid Biopsy of Prostate Cancer (5U01CA214194-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10004588. Licensed CC0.

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