This clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. This clinical study would allow monitoring of total tissue damage in blood samples as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy, which could help clinicians make treatment decisions. Detection of excessive tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions which could include patient therapies that would reduce or prevent the problems that occur due to radiotherapy of their cancer.
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) doses are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy and should help identify patients at high risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity, especially gastrointestinal toxicities.
Study Type
OBSERVATIONAL
Collection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test.
University of Florida, Gainesville, FL
Gainesville, Florida, United States
UF Health Proton Therapy Institute
Jacksonville, Florida, United States
NY Cancer and Blood Specialists
New York, New York, United States
NY Cancer and Blood Specialists
Port Jefferson Station, New York, United States
To determine the cut-off values from the RadTox test results during early radiation treatment from all evaluable subjects to differentiate high toxicity score from average or low toxicity score.
The cut-off values of all evaluable subjects will be measured based on the Receiver Operating Characteristic (ROC) analysis to optimize detection of true high-risk patients with ≥60% sensitivity and ≥60% specificity allowing for an acceptable number of high-risk classified but normal-risk patients.
Time frame: 1 year after radiotherapy
To determine the cut-off values from the RadTox test performed during early radiation treatment with patients categorized according to demographics and treatment options to differentiate high toxicity score from average or low toxicity score.
The RadTox test results will be measured to determine the cut-off values according of patients' demographics and treatment options such as fractionation and radiation modality.
Time frame: 1 year after radiotherapy
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NY Cancer and Blood Specialists
The Bronx, New York, United States