Prostate CancerRADTOXNCT02941029
RADTOX: Measuring Radiation Toxicity Using Circulating DNA
An observational study of Prostate Cancer, run by University of Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Plasma Blood collection
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with undergoing radiation therapy for prostate cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida Health
Gainesville, Florida, 32610
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
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.
Read the 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
- Being tested
- Plasma Blood collection
- Keywords
- Radiation, Chemotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Blood collectionOther
Also called Plasma/Blood Collection
Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Plasma Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0
Measured: 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
Measured: 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
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- DiaCarta, Inc., National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Randal Henderson, MD, MBA, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941029
- Sponsor's protocol ID
- IRB201601961-N
- Other IDs
- 261201600063C-0-0-1, OCR15535
- Acronym
- RADTOX
- Status last verified
- Aug 2019
- First submitted
- 13 Oct 2016
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with necessary government agencies, the sponsor, and participating providers and institutions as defined in the informed consent document.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADTOX: Measuring Radiation Toxicity Using Circulating DNA
- ClinicalTrials.gov ID
- NCT02941029
- Acronym / sponsor ID
- RADTOX / IRB201601961-N
- Conditions
- Prostate Cancer
- Keywords
- Radiation, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- DiaCarta, Inc., National Institutes of Health (NIH)
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluate toxicity biomarkers | – | Other: Plasma Blood collectionInvestigators 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with undergoing radiation therapy for prostate cancer
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Blood collectionAlso: Plasma/Blood CollectionPlasma blood collection is collected at specific intervals prior to and during radiation treatment. | Other | Evaluate toxicity biomarkers |
Primary outcome
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0
Time frame: 9 Months
2 secondary outcomes
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores
Time frame: 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
Time frame: 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No. Data will be shared with necessary government agencies, the sponsor, and participating providers and institutions as defined in the informed consent document.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randal Henderson, MD, MBA principal investigator
clinical professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0 (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.