TOPIC 345: PREDICTIVE BIOMARKERS OF PROSTATE CANCER PATIENT SENSITIVITY FOR RADIATION LATE EFFECTS

To address the goals of developing ""predictive biomarkers of adverse reactions to radiation treatment""we propose to perform a multi site analytic validation of the product""metabolite panel kit""developed in the Phase I SBIR effortResults of plasma metabolite analysis in defined cohorts of patients treated with SBRT for prostate cancer will be tested for precisionaccuracy and reproducibility in three independentgeographically distributed testing laboratoriesClinical samples obtained from patients with prostate cancers and samples spiked with known quantities of metabolites will be distributed for analytic validation of Shuttle s metabolite ""kit""The data derived in the Phase I effort have defined metabolite panels for potential use as predictive biomarkers of radiation late effectsherewe propose three technical objectivesTo manufacturemetabolite panel ""kits"" and analysis softwareTest and validate the performance of kits and software at three independent sites andWith the assistance of regulatory consultant and FDA inputdesign an expanded multi institutional validation clinical trial to test the metabolite panel kit for use as a potential ""metabolite biomarker"" for clinical applicationDemonstration of proof of principle in patients with prostate cancer may support development and commercialization of the metabolite biomarker product