# Project 2: Integrating a Novel MiPS-Based Next-Generation Sequencing Urine Assay for the Early Detection of Unfavorable Risk Prostate Cancer

> **NIH NIH P50** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2020 · $418,673

## Abstract

Project 2 of the Michigan Prostate SPORE seeks to improve the early detection of unfavorable risk prostate
cancer (PCa) by employing a novel urine-based next-generation sequencing (NGS) assay. Recent studies
have demonstrated that men with certain germline genetic alterations (e.g., BRCA 1/2 and Lynch syndrome)
may be at increased risk of potentially aggressive PCa. Men at increased genetic risk represent a newly
recognized group in whom early detection is particularly compelling. Generally speaking, a central problem
inherent to PCa screening is the profound overdiagnosis of Gleason 6 (low risk) disease. To counterbalance
the overtreatment of Gleason 6 PCa, a number of active surveillance (AS) strategies have been introduced.
Transition to definitive treatment (e.g., surgery or radiation) can be triggered by evidence of risk reclassification
often due to grade progression. Improved early detection of grade progression in men with previously
diagnosed Gleason 6 PCa on AS represents a major opportunity to improve and optimize resource utilization
(prostate biopsy and MRI) as well as the diagnosis of clinically significant PCa. How to reliably identify
potentially aggressive PCa so treatment can be appropriately recommended continues to represent a critical
knowledge gap. Building on prior work from a successful SPORE project involving the Mi Prostate Score
(MiPS) test (using transcription-mediated amplification quantification of urine KLK3, PCA3, and
TMPRSS2:ERG), we have developed a novel urine-based NGS assay (MiPS-NGS) to detect unfavorable risk
(≥Gleason 7) PCa. MiPS-NGS is a targeted RNA-seq assay comprised of 83 prostate-, PCa-, and aggressive
PCa-specific transcripts (e.g., lncRNAs, ETS genes fusions, HOXB13). We hypothesize that MiPS-NGS can
improve the early detection of unfavorable risk PCa and will test this through the following Specific Aims:
Aim 1: To assess the utility of MiPS-NGS as a PCa early detection assay in men at high genetic risk.
Aim 2: To determine whether MiPS-NGS can predict grade progression in men on AS. Sub-Aim 2.1: To test
MiPS-NGS alone for the early detection of grade progression in two prospective AS cohorts. Sub-Aim 2.2: To
develop a multi-dimensional clinical tool based on MiPS-NGS to optimize early detection of grade progression
in men on AS.
Upon successful completion of this project, we will have established a role for our innovative urine NGS assay
in the early detection of unfavorable risk PCa in two important contexts: 1) men at high genetic risk and 2) AS.
Our interdisciplinary team, comprised of experts in clinical management, genomics, bioinformatics,
biostatistics, and cancer genetics, coupled with our unique institutional resources (Michigan Urological Surgery
Improvement Collaborative (MUSIC), University of Michigan Prostate Cancer Risk Clinic (PCRC), and the
Karmanos Cancer Institute) and collaborations (University of Washington/Fred Hutchinson Cancer Research
Center and the National Cancer Institu...

## Key facts

- **NIH application ID:** 10006871
- **Project number:** 5P50CA186786-07
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Ganesh S Palapattu
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $418,673
- **Award type:** 5
- **Project period:** 2014-09-11 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006871

## Citation

> US National Institutes of Health, RePORTER application 10006871, Project 2: Integrating a Novel MiPS-Based Next-Generation Sequencing Urine Assay for the Early Detection of Unfavorable Risk Prostate Cancer (5P50CA186786-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10006871. Licensed CC0.

---

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