# Noninvasive Risk Stratification of Prostate Cancer Using Cell-Free Nucleic Acids

> **NIH NIH K08** · STANFORD UNIVERSITY · 2021 · $283,673

## Abstract

PROJECT SUMMARY/ABSTRACT
Every year, more than 161,000 men in the U.S. are diagnosed with prostate cancer. While prostate
cancer remains a significant cause of cancer related mortality, early screening efforts are hampered by
the fact that the majority of cases are not imminently deadly and active treatments or re-biopsies have
adverse side effects. The goal of this proposal is to pioneer new non-invasive diagnostics to distinguish
between high-risk versus low-risk prostate cancers in order to guide clinical management.
The core hypothesis of this proposal is that copy number variations and methylation markers can be
found non-invasively in circulating nucleic acids as a surrogate for invasive tissue markers, and these
markers can risk stratify localized prostate cancers. The first aim will evaluate two non-invasive
biomarkers for prostate cancer using next-generation sequencing (NGS)-based approaches. Plasma
and urine samples will be tested for copy number variations and methylation markers, and compared
against concurrent prostate cancer tissue taken from prostate surgery. The second aim will evaluate
the non-invasive approaches in the first aim for the ability to risk stratify localized prostate cancer in a
cross-sectional study.
In this K08 Mentored Clinical Scientist Research Career Development Award application, the
applicant, Wei Gu, MD, PhD, is a board certified Clinical Pathologist at UCSF Department of Laboratory
Medicine. This proposal encompasses a five-year plan to enhance his research and professional skills
with the goal of becoming an independent physician-scientist focused on advancing non-invasive
testing using cell-free nucleic acids as cancer biomarkers.
Essential components of the career development plan are: (1) mentorship from a multidisciplinary team
of scientists and physician-scientists with expertise in advanced molecular techniques, bioinformatics,
biostatistics, and clinical study design; (2) formal didactics to expand on knowledge in clinical study
design, cancer biology, bioinformatics, and professional development; (3) laboratory testing and
analysis of cell-free DNA as biomarkers for prostate cancer; (4) professional development in the
transition to independence, and (5) data collection for an R01 application. A mentorship and
multidisciplinary scientific committee has been assembled to facilitate the proposal aims and
progression towards independence. This plan will be implemented at University of California, San
Francisco, which provides an exceptional research environment, state-of-art facilities, and a supportive
scientific community that will be an ideal environment to foster career development and project
success.

## Key facts

- **NIH application ID:** 10217044
- **Project number:** 5K08CA230156-05
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Wei Gu
- **Activity code:** K08 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $283,673
- **Award type:** 5
- **Project period:** 2020-11-16 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10217044

## Citation

> US National Institutes of Health, RePORTER application 10217044, Noninvasive Risk Stratification of Prostate Cancer Using Cell-Free Nucleic Acids (5K08CA230156-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10217044. Licensed CC0.

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