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A multimodal liquid biopsy assay to quantify androgen receptor’s somatic alterations in metastatic castration-resistant prostate cancer.

Award Number: UH2CA307747
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/16/2026
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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A multimodal liquid biopsy assay to quantify androgen receptor’s somatic alterations in metastatic castration-resistant prostate cancer. - PROJECT SUMMARY The high mortality rate of metastatic prostate cancer underscores the urgent need for a sensitive detection assay for androgen receptor (AR) alterations, which are primary drivers of resistance to AR-targeted therapies in metastatic castrate-resistant prostate cancer (mCRPC). AR alterations, including amplifications, mutations, and splicing variants, are present in 50-70% of mCRPC patients and are associated with worse outcomes, underscoring the importance of targeting AR alterations to optimize treatment and guide personalized therapy. Despite extensive genomic knowledge with the potential to enhance clinical care and guide future clinical trial design, the discoveries of AR alterations in mCRPC have not been translated into clinical practice due to the lack of assay development and implementation. This project aims to bridge this gap by developing and validating a plasma-based multimodal digital PCR assay for AR alterations as a Laboratory Developed Test. In Aim 1, we will determine and validate the analytical performance of the assay by quantifying AR somatic alterations, ensuring its accuracy and reproducibility. In Aim 2, we will establish the clinical utility of the assay by evaluating its prognostic and predictive capabilities in a cohort of mCRPC patients. This minimally invasive liquid biopsy approach will facilitate the monitoring of clonal evolution and treatment resistance, capture genomic heterogeneity across metastatic sites, and provide a cost-effective, sensitive tool for identifying clinically relevant AR alterations that inform personalized therapy, ultimately refining current and future clinical practice in mCRPC and improving patient outcomes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $225,511 )
2026	2026	H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE HOSPITAL, INC.	12902 USF MAGNOLIA DR	TAMPA	FL	33612	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	1	3/19/2026	NEW	$225,511
														Subtotal = $225,511

Grand Total All Awards = $225,511

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A multimodal liquid biopsy assay to quantify androgen receptor’s somatic alterations in metastatic castration-resistant prostate cancer.

Award Number: UH2CA307747

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/16/2026

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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