Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

Plasma Blood collection

Randal Henderson, MD, MBA

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.

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.

RADTOX: Measuring Radiation Toxicity Using Circulating DNA

Data will be shared with necessary government agencies, the sponsor, and participating providers and institutions as defined in the informed consent document.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RADTOX: Measuring Radiation Toxicity Using Circulating DNA	NCT02941029	Prostate Cancer	Plasma Blood co...	18 Years -	University of Florida
RADTOX: Measuring Radiation Toxicity Using Circulating DNA	NCT02941029	Prostate Cancer	Plasma Blood co...	18 Years -	University of Florida
RADTOX: Measuring Radiation Toxicity Using Circulating DNA	NCT02941029	Prostate Cancer	Plasma Blood co...	18 Years -	University of Florida

Spots Global Cancer Trial Database for plasma blood collection