# Discovery and qualification of transcriptomic biomarkers for the early detection of aggressive prostate cancer

> **NIH NIH U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2020 · $574,716

## Abstract

Project Summary
This application proposes the formation of a University of Michigan (UM) EDRN Biomarker Development Lab
(BDL). Through previous EDRN BDLs, our team has characterized multiple important prostate cancer
biomarkers, most notably TMPRSS2-ETS gene fusions. Through collaboration with an EDRN Clinical
Validation Center (CVC; Dr. Sanda PI), we have developed, validated and clinically implemented Mi-Prostate
Score (MiPS), a prostate cancer early detection test incorporating urine quantification of two prostate cancer
specific transcripts—the TMPRSS2:ERG gene fusion and PCA3—with serum PSA. Introduced in our CLIA
laboratory (and now with New York State approval), MiPS helps shared decision making after PSA testing
based on individualized risk predictions of aggressive prostate cancer on biopsy. Here, using this work as a
model, we will discover and characterize aggressive prostate cancer transcriptomic biomarkers, focusing on
long non-coding RNAs (lncRNAs). Although lncRNA biomarker utility has been largely unexplored, we recently
characterized the lncRNA compendium (“MiTranscriptome”), identifying several prostate cancer-specific and
aggressive prostate cancer-specific lncRNAs. Supporting our proposed approach, we have performed initial
validation of the lncRNA SChLAP1 as an aggressive prostate cancer specific biomarker in tissues. Likewise,
we have developed RT-PCR based next generation sequencing (NGS) panels capable of quantifying
multiplexed transcriptomic biomarkers in archived tissue and urine. Here, in three Aims, we will nominate and
develop transcriptomic biomarkers as predictors of aggressive prostate cancer both at and prior to diagnosis.
In Aim 1, we will identify novel aggressive prostate cancer-associated transcriptomic alterations from our
MiTranscriptome analysis. We will develop single gene and multiplexed NGS assays to study these
lncRNAs/coding transcripts as aggressive prostate cancers specific biomarkers. In Aim 2 we will characterize
transcripts from Aim 1 as tissue based aggressive prostate cancer biomarkers. Following our previous
approach with SChLAP1, we will develop individual in situ hybridization assays and a multiplexed NGS panel
to characterize these transcripts in well characterized prostate cancer tissue cohorts. In Aim 3, we will
characterize transcripts identified in Aim 1 as non-invasive, urine-based aggressive prostate cancer early
detection biomarkers. Through collaboration with Hologic/Gen-Probe (our industry partner on MiPS), we will
develop and assesses the performance of individual prioritized biomarkers using their platform on our
biobanked urine samples. Additionally, using multiplexed NGS, we will also characterize the performance of a
panel of transcriptomic biomarkers as an alternative/complementary approach. As recognized by the EDRN,
novel aggressive prostate cancer specific biomarkers are urgently needed. Importantly, our approach extends
beyond prostate cancer and our BDL, and our group ha...

## Key facts

- **NIH application ID:** 9986704
- **Project number:** 5U01CA214170-05
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** ARUL M CHINNAIYAN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $574,716
- **Award type:** 5
- **Project period:** 2016-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986704

## Citation

> US National Institutes of Health, RePORTER application 9986704, Discovery and qualification of transcriptomic biomarkers for the early detection of aggressive prostate cancer (5U01CA214170-05). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9986704. Licensed CC0.

---

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