# BCC for Prostate Cancer: Discovery and Translation of Biomarkers for Clinical Unmet Needs

> **NIH NIH U2C** · JOHNS HOPKINS UNIVERSITY · 2024 · $936,098

## Abstract

Active surveillance (AS) is the preferred management option for low risk prostate cancer (PCa) patients who
would benefit from conservative treatment. However, due to the lack of reliable methods in the initial clinical
evaluation to identify true low-risk PCa patients for AS enrollment and during AS monitoring to detect a rising
risk of progression, patients who could benefit from conservative management through AS are often over-treated,
yet at the same time patients initially chosen for AS with a missed high-risk disease are under-treated. The goal
of the proposed EDRN Biomarker Characterization Center (BCC) is to develop and validate in vitro diagnostic
multivariate index assays (IVDMIA) that combine a panel of biomarkers into a single-valued numerical index with
the intended use for the clinical unmet needs for 1) assisting in the preoperative assessment of PCa
aggressiveness and decision for enrollment into AS; and 2) detecting a rising risk of progression during AS to
triage patients for additional and possibly more invasive procedures for needed disease reclassification. The
objective for the IVDMIA development is to improve specificity while maintaining a high negative predictive value
in order to safely enroll more patients with true low-risk PCa into AS and reduce the number of unnecessary
biopsies and or costly workup procedures for patients in AS. To achieve this goal, we propose an integrated
BCC at the JHU consisting of a multi-disciplinary team including PIs from current EDRN BDL (Dr. Hui Zhang)
and BRL (Dr. Daniel W. Chan), and a previous CVC (Dr. Alan Partin). The targeted population is JHU AS patients
with >20 years of enrollment and clinical follow-up. Our team has many years of experience in biomarker
discovery, verification, validation, and translation into clinical diagnostics and the development of IVDMIA, e.g.
OVA1, the 1st proteomics IVDMIA cleared by the FDA (2009). We plan to take advantage of the serum
biomarkers already discovered for aggressive PCa from our current BDL and BRL and begin the verification and
validation in the targeted AS population by our BRL. In parallel, our BDL will focus on the discovery of new
candidate serum, urine and tissue biomarkers by applying cutting edge technologies to the AS population, such
as mass spectrometry based high throughput proteomics, protein modifications, and single cell analysis of laser-
capture-microdissected tissues. We plan to combine these biomarkers into IVDMIAs. Finally, we will work with
our industry partners to translate these IVDMIAs into CLIA certified and/or FDA cleared/approved clinical
diagnostics. We believe with these innovative, yet, practical approaches, our BCC offers the best opportunity to
make significant contributions to the EDRN network and address the critical clinical unmet needs for PCa
patients. If the over-treatment, under-treatment, decrease in unnecessary biopsies, and increase in biopsy
accuracy can be successfully addressed, the morbiditie...

## Key facts

- **NIH application ID:** 10890722
- **Project number:** 5U2CCA271895-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** DANIEL Wanyui CHAN
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $936,098
- **Award type:** 5
- **Project period:** 2023-07-20 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10890722

## Citation

> US National Institutes of Health, RePORTER application 10890722, BCC for Prostate Cancer: Discovery and Translation of Biomarkers for Clinical Unmet Needs (5U2CCA271895-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10890722. Licensed CC0.

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