IGF OT IGF PREDICTIVE BIOMARKERS OF PROSTATE CANCER PATIENT SENSITIVITY FOR RADIATION LATE EFFECTS

Patients treated for prostate cancer may experience treatment related late effects thatadversely affect quality of life and may prove life threatening The objective of this Phase I SBIRapplication is to determine the technical and commercial feasibility of a biomarker panelpredictive of radiation mediated late effects in patients treated for prostate cancer We willdevelop a metabolite signature of radiation responses in a cohort of patients undergoingstereotactic body radiation therapy SBRT for prostate cancer Analysis of banked plasmasamples will be correlated with clinical outcomes to identify markers of urinary andgastrointestinal late effects for validation in a larger clinical population to be proposed in asubsequent Phase II application The Phase II effort will allow Shuttle Pharmaceuticals toadvance its proposed commercialization plan and to raise capital to support validation clinicaltrials leading to FDA approval Patients treated with stereotactic body radiation therapy SBRT for prostate cancers onan IRB approved protocol have banked clinical specimens and detailed monitoring of quality oflife parameters Sub sets of these patients have developed urinary incontinence UI symptomatic urinary flare USF obstructed voiding symptoms retention UR and radiationproctitis RP We have used high resolution mass spectrometry based metabolomics lipidomicprofiling to analyze this unique cohort of patient samples and propose here to leverage ourestablished analytical platform to advance product development and validation of a biomarkerpanel predictive of radiation toxicities Metabolites in plasma from a cohort of de identifiedpatients will be analyzed to develop a kit supporting metabolomic analysis to serve as abiomarker panel predictive of patient susceptibility for radiation late effects