Prostate Cancer Clinical Trial
Official title:
RADTOX: Measuring Radiation Toxicity Using Circulating DNA
This research study is being done to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications. This research study would allow monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that could give an initial result within a few days that would help clinicians make treatment decisions. Detection of unusual tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions that could include patient therapies that would reduce or prevent the problems that occur due to treatment of their cancer.
Currently, a patient's risk for toxicity is based almost exclusively on population
statistics. Radiation (and chemotherapy) dose are based on phase I data and not on the
individual's specific genetics or hidden predispositions. RadTox measures cell damage within
24 hours of radiation exposure and should help identify patients at higher risk for radiation
complications. This should allow physicians to adjust radiation field size and dose to
minimize long-term toxicity.
Patients undergoing radiation treatment for stage I to III prostate cancer, using protons or
X-rays, either as primary treatment or consolidation after prostatectomy (positive margins or
prostate-specific assay [PSA]-related indications) will be eligible. Hormone treatment will
be allowed.
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