Clinical trial NCT02941029: RADTOX: Measuring Radiation Toxicity Using Circulating DNA
Official title: RADTOX: Measuring Radiation Toxicity Using Circulating DNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Radiation
Chemotherapy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: DiaCarta, Inc.
name: National Institutes of Health (NIH)
First posted: 2016-10-21
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with undergoing radiation therapy for prostate cancer

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0
timeFrame: 9 Months
Secondary outcomes:
measure: Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores
timeFrame: 9 Months
measure: Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared and visual analog scales of toxicity
timeFrame: 9 Months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
Study officials:
affiliation: clinical professor
name: Randal Henderson, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: