Federal Cooperative Agreement Award Summary

H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. received a $225,511 Cooperative Agreement from the National Cancer Institute under the Cancer Detection and Diagnosis Research program (CFDA 93.394) on March 16, 2026, with a completion date of February 29, 2028. The award supports the development and validation of a plasma-based multimodal digital polymerase chain reaction (PCR) assay to detect and quantify androgen receptor (AR) somatic alterations in metastatic castration-resistant prostate cancer (MCRPC) patients. This minimally invasive liquid biopsy assay will serve as a laboratory-developed test to identify AR alterations—including amplifications, mutations, and splicing variants—which occur in 50-70% of MCRPC patients and drive resistance to AR-targeted therapies.

The project encompasses two primary aims: (1) validation of the assay's analytical performance to ensure accuracy and reproducibility in quantifying AR somatic alterations, and (2) establishment of clinical utility by evaluating the assay's prognostic and predictive capabilities in a MCRPC patient cohort. The resulting tool will enable monitoring of clonal evolution and treatment resistance, facilitate detection of genomic heterogeneity across metastatic sites, and provide a cost-effective mechanism for identifying clinically relevant AR alterations to guide personalized therapy selection and improve patient outcomes in MCRPC management.