RADTOX: Measuring Radiation Toxicity Using Circulating DNA

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Consent to participate in the study and a signed and dated an institutional review board (IRB)-approved consent form conforming to federal and institutional guidelines.
≥ 18 years of age.
Patients must have an Eastern Cooperative Oncology Group (An ECOG) performance status of 0 or 1.
A diagnosis of adenocarcinoma of the prostate.
Not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery.
Clinically stage I to III tumors.

Exclusion Criteria

Metastatic disease.
A history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
Prior pelvic radiation therapy for any reason.
Psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (PI), would preclude the patient from meeting the study requirements.

Arm && Interventions

Group	Intervention	Description
Evaluate toxicity biomarkers	Plasma Blood collection	Investigators will determine if measurement of circulating DNA from tumor and normal tissues shortly after RT provides an early and quantitative measure of risk of radiation-related complications. It will be necessary to collect blood specimens prior to and during the first week of radiation therapy.

Primary Outcome Measures

Name	Time	Method
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0	9 Months

Secondary Outcome Measures

Name	Time	Method
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores	9 Months
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared and visual analog scales of toxicity	9 Months

Locations (2): University of Florida Health
🇺🇸
Gainesville, Florida, United States
University of Florida Health Proton Therapy Institute
🇺🇸
Jacksonville, Florida, United States

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