RADTOX: Measuring Radiation Toxicity Using Circulating DNA

NCT ID: NCT02941029

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-07-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Plasma Blood collection

Intervention Type: OTHER

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

Interventions

Plasma Blood collection

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

Intervention Type: OTHER

Other Intervention Names

Plasma/Blood Collection

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

DiaCarta, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randal Henderson, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

clinical professor

Locations

University of Florida Health

Gainesville, Florida, United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

261201600063C-0-0-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR15535

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201601961-N

Identifier Type: -

Identifier Source: org_study_id