Clinical trial · Observational
RADTOX: Measuring Radiation Toxicity Using Circulating DNA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma Blood collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Evaluate toxicity biomarkers
- description
- 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.
- interventionNames
- Other: Plasma Blood collection
Primary outcomes (1)
- 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 (2)
- measure
- Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores
- timeFrame
- 9 Months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available