RADTOX: Measuring Radiation Toxicity Using Circulating DNA

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.

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.