# A blood test to identify prostate cancer patients at risk for visceral metastasis

> **NIH NIH R01** · CEDARS-SINAI MEDICAL CENTER · 2020 · $601,750

## Abstract

Project Summary
 The long-term goal of this R01 proposal is to develop a circulating tumor cell-based assay
to identify prostate cancer (PCa) patients who are at risk for developing visceral metastasis
(VM). Drs. Posadas (Cedars-Sinai) and Tseng (CytoLumina) have formed a unique and
functional academic/industrial partnership geared toward this project.
 VM in metastatic, castration-resistant PCa (mCRPC) is an emerging and unaddressed
problem. Patients with VM have significantly foreshortened cancer-specific survival and die from
organ failure in a fashion distinct from patients with bone-predominant disease. VM are typically
found on imaging requested only when organ function is already compromised-typically late in
the clinical course but affect over 45% of patients with advanced PCa. Early treatment can
improve outcome but this requires timely detection. Thus, there is an unmet need to identify
patients at risk for VM to customize imaging surveillance and create an opportunity to alter
disease trajectory.
 Circulating tumor cells (CTCs) are rare cancer cells that can be isolated from whole blood.
The NanoVelcro assay is a novel cellular isolation technology introduced by CytoLumina that is
capable of identifying CTCs in small volumes of blood (as little as 1 mL). Use of NanoVelcro
assay has led to the identification of CTC subsets based on nuclear morphology including those
with nuclei less than 8.5 µm in diameter called very small nuclear CTCs (vsnCTCs). We have
found that the appearance of vsnCTCs is associated with the presence of VM in men with PCa.
 We hypothesize that vsnCTCs appear before the VM are detectable by conventional
radiographic assessment in mCRPC. This hypothesis will be tested by (aim 1) an analysis of
CTC samples that have been serially collected over the past 3 years in our annotated
CTC/blood bank – a unique and invaluable resource for this work and, (aim 2) a prospective
CTC analysis of men with mCRPC. Our early work shows that vsnCTCs appear months before
the VM are detectable by conventional imaging techniques.
 This investigative project will create an opportunity for early imaging and therapy which
can change the clinical course for patients. As a byproduct, this work will create a new clinical
space in PCa by identifying men at risk for VM. The NanoVelcro vsnCTC Assay will provide a
simple, minimally-invasive, and cost-effective means of identifying mCRPC patients at risk for
VM, thereby allowing physicians to personalize patient monitoring, treatment, and therapy.

## Key facts

- **NIH application ID:** 9928027
- **Project number:** 5R01CA218356-04
- **Recipient organization:** CEDARS-SINAI MEDICAL CENTER
- **Principal Investigator:** Edwin Melencio Posadas
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $601,750
- **Award type:** 5
- **Project period:** 2017-06-19 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9928027

## Citation

> US National Institutes of Health, RePORTER application 9928027, A blood test to identify prostate cancer patients at risk for visceral metastasis (5R01CA218356-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9928027. Licensed CC0.

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