RADTOX: Measuring Radiation Toxicity Using Circulating DNA

NCT02941029 | Completed DMC

• 3 other identifiers: IRB201601961-N261201600063C-0-0-1OCR15535
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Radiation; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Evaluate toxicity biomarkers

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.

Other: Plasma Blood collection

Interventions

Plasma Blood collection OTHER

Plasma blood collection is collected at specific intervals prior to and during radiation treatment.

Also known as: Plasma/Blood Collection

Evaluate toxicity biomarkers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with undergoing radiation therapy for prostate cancer

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.

Sponsors & Collaborators

• University of Florida: lead
• DiaCarta, Inc.: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Florida Health

Gainesville, Florida, 32610, United States

Location

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

collection of plasma

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Randal Henderson, MD, MBA

  clinical professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)