# Clinical Qualification of Imaging and Fluid-Based Tumor Monitoring Biomarkers for Metastatic Castration Resistant Prostate Cancer

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2020 · $719,712

## Abstract

Metastatic prostate cancer is the second largest cause of cancer-related death in American men. A major
obstacle to their treatment and to developing new drugs for this disease is the lack of reliable quantitative
treatment monitoring methods. Fluid-based tumor monitoring using circulating tumor cells (CTC) has
recently proven valuable for prognosis and predicting response to treatment. Current imaging methods for
treatment monitoring in prostate cancer involve lesion-counting of new bone metastases or selected index
lesions of soft tissue disease; both focus on progression only and cannot assess the full disease burden.
This proposal deploys two validated methods, automated bone scan index (aBSI) and lymph node
segmentation, to quantify standard imaging results so that a measure of total disease burden on imaging
can be integrated with CTC data in a predictive model. The hypothesis that this model will outperform
current methods for monitoring response to therapy will be tested via these specific aims: 1) Correlate
quantitative post-treatment changes in tumor burden as assessed by imaging and CTC’s; 2) Determine
whether a combination of fluid-based tumor monitoring (liquid biopsy) and an imaging assay is more
powerful than either assay alone in prognosticating for survival; 3) Identify the optimal combination of liquid
biopsy and imaging for different therapies. Models will be built to predict overall survival using imaging,
CTC, and prognostic factor data from phase III clinical trials of first-line treatments, docetaxel, docetaxel +
radium-223, and abiraterone + prednisone, for an advanced stage of disease, metastatic castration-
resistant prostate cancer (mCRPC). Clinical trials including this data are available for analysis due to the
recommendations for serial imaging (CT and bone scintigraphy) and CTC assessment as endpoints in the
Prostate Cancer Working Group (PCWG) 3 guidelines, co-authored by the study team. The results of this
study will create the first reliable, multiparametric, and fully quantitative biomarker that captures clinically
meaningful indices of both response and progression in mCRPC; generate evidence to support its inclusion
in future PCWG guidelines; and develop methods applicable to new imaging modalities.

## Key facts

- **NIH application ID:** 9974088
- **Project number:** 1R01CA240759-01A1
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** MICHAEL J MORRIS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $719,712
- **Award type:** 1
- **Project period:** 2020-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9974088

## Citation

> US National Institutes of Health, RePORTER application 9974088, Clinical Qualification of Imaging and Fluid-Based Tumor Monitoring Biomarkers for Metastatic Castration Resistant Prostate Cancer (1R01CA240759-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9974088. Licensed CC0.

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