RADTOX: Measuring Radiation Toxicity Using Circulating DNA
Completed
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02941029
- Run by
- University of Florida
- People needed
- 68
- Starts
- 2016-10-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2019-08-29
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Florida Health — Gainesville, Florida, United States
- University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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