Prostate CancerNCT04580667
Determination of Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict GI Radiation Toxicity
An observational study of Prostate Cancer, run by DiaCarta, Inc. at 5 sites in United States.
Trial summary
This clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. Read more about this study
- Who is it for?
- Ages 30 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Collection of plasma samples
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2020to 6 Sep 2023
- How long will I take part?
- 12 Months
- 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 30 to 85 years
- Men only
- Adult, Older adult
Study population: Male patients with undergoing radiation therapy for prostate cancer
Who may be able to join
- Men diagnosed with adenocarcinoma of the prostate who have not received previous treatment (defined as prostatectomy, transurethral resection of the prostate [TURP], radiation of the pelvis, and GreenLight Laser Therapy) except for short-term (≤6 months) Androgen Deprivation Therapy (ADT) according to National Comprehensive Cancer Network (NCCN) guidelines.
- Candidate for definitive prostate radiotherapy (either IMRT or proton).
- Patients to be treated with IMRT should have all radiation treatment planned with IMRT, whereas patients to be treated with protons should have all radiation treatment planned with protons (including pelvic nodes if treated).
- Localized prostate cancer, as confirmed by staging with Prostate-Specific Antigen (PSA), biopsy, Gleason score, and clinical stage.
- Nuclear medicine bone imaging is required for confirmation of the absence of overt metastatic disease in bones if any high-risk criteria are identified (clinical stage T3a or higher; or 1-4 cores of Gleason score 8 [NCCN Grade Group 4] or 4+5; or PSA ≥20 ng/mL).
- Diagnosed with any of the NCCN initial groups (i.e., Very-Low-Risk, Low-Risk, Intermediate-Risk [both Favorable and Non-Favorable Intermediate-Risk]; High-Risk; or Very-High-Risk) (see Appendix III for NCCN classifications of various risk groups). For Very-High-Risk, subjects are to have negative prostate cancer specific PET/CT imaging for confirmation of being metastasis free.
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- The score for Question 16 (i.e., "Overall, how big a problem have your bowel habits been for you during the last 4 weeks?") of the Bowel Habits section of Expanded Prostate Cancer Index Composite (EPIC) questionnaire must be 2 or below.
- 30-85 years of age at the time of consent.
- Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status 0 - 2.
Who cannot join
- Findings of metastatic disease (nodal or distant, >N1 or M1).
- Prior prostatectomy, TURP, radiation of the pelvis, or GreenLight Laser Therapy.
- History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
- The score for Question 16 (i.e., "Overall, how big a problem have your bowel habits been for you during the last 4 weeks?") of EPIC questionnaire is 3 or above.
- Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic) or documented history of inflammatory bowel disease requiring intervention.
- Prior pelvic radiotherapy for any reason.
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- Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up.
- Documented decisionally impaired persons who have a diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent.
- Subjects who participated in a clinical trial of an investigational device, drug or biologics within the past 30 days.
- Subjects who are currently undergoing any cancer drug treatment. However, patients who had received cancer drug treatment and stopped the treatment for >4 weeks prior to the start of radiotherapy can be included. (Hormone therapy is allowed if judged appropriate and necessary by the treating physicians.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Florida, Gainesville, FL
Gainesville, Florida, 32610
UF Health Proton Therapy Institute
Jacksonville, Florida, 32206
NY Cancer and Blood Specialists
New York, New York, 10028
NY Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
NY Cancer and Blood Specialists
The Bronx, New York, 10469
About this study
Official title: Prospective Observational Exploratory Clinical Study to Determine the Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict Gastrointestinal Radiation Toxicity Using Circulating Cell Free DNA Directly From Plasma
This clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. This clinical study would allow monitoring of total tissue damage in blood samples as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy, which could help clinicians make treatment decisions. Detection of excessive tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions which could include patient therapies that would reduce or prevent the problems that occur due to radiotherapy of their cancer.
Read the detailed description
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) doses are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy and should help identify patients at high risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity, especially gastrointestinal toxicities.
- Conditions
- Prostate Cancer
- Being tested
- Collection of plasma samples
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of plasma samplesOther
Collection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test.
| Study group | Role | What they receive |
|---|---|---|
| Evaluate toxicity biomarkers | Investigators will determine if measurement of circulating DNA from normal tissues shortly after the start of radiotherapy provides an early indication of patients at high risk of radiation-related toxicity. Blood specimens for RadTox test will be collected: (a) prior to radiotherapy (T0); (b) after the 2nd but before the 4th radiotherapy dose during week 1 (T1); (c) on Week 2 during radiotherapy (T2); and (d) 3 months after completion of radiotherapy (T3). Receives: Other: Collection of plasma samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the cut-off values from the RadTox test results during early radiation treatment from all evaluable subjects to differentiate high toxicity score from average or low toxicity score.
The cut-off values of all evaluable subjects will be measured based on the Receiver Operating Characteristic (ROC) analysis to optimize detection of true high-risk patients with ≥60% sensitivity and ≥60% specificity allowing for an acceptable number of high-risk classified but normal-risk patients.
Measured: 1 year after radiotherapy
Secondary outcomes (1)
To determine the cut-off values from the RadTox test performed during early radiation treatment with patients categorized according to demographics and treatment options to differentiate high toxicity score from average or low toxicity score.
The RadTox test results will be measured to determine the cut-off values according of patients' demographics and treatment options such as fractionation and radiation modality.
Measured: 1 year after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Why it stopped: The sponsor declared bankruptcy
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.
- 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
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- DiaCarta, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann K Vallerga, PhD, MBA, Principal investigator, DiaCarta, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580667
- Sponsor's protocol ID
- DIA.0009
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2020
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Exploratory Clinical Study to Determine the Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict Gastrointestinal Radiation Toxicity Using Circulating Cell Free DNA Directly From Plasma
- ClinicalTrials.gov ID
- NCT04580667
- Acronym / sponsor ID
- DIA.0009
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor declared bankruptcy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DiaCarta, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- 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 clinical study is conducted to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications, especially related to gastrolintestinal (GI) toxicities. This clinical study would allow monitoring of total tissue damage in blood samples as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy, which could help clinicians make treatment decisions. Detection of excessive tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions which could include patient therapies that would reduce or prevent the problems that occur due to radiotherapy of their cancer.
Detailed description
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) doses are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage as early as after the 2nd but before the 4th radiotherapy dose during week 1 of radiotherapy and should help identify patients at high risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity, especially gastrointestinal toxicities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluate toxicity biomarkers | – | Other: Collection of plasma samplesInvestigators will determine if measurement of circulating DNA from normal tissues shortly after the start of radiotherapy provides an early indication of patients at high risk of radiation-related toxicity. Blood specimens for RadTox test will be collected: (a) prior to radiotherapy (T0); (b) after the 2nd but before the 4th radiotherapy dose during week 1 (T1); (c) on Week 2 during radiotherapy (T2); and (d) 3 months after completion of radiotherapy (T3). |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Male patients with undergoing radiation therapy for prostate cancer
Key inclusion criteria (9 listed)
- Men diagnosed with adenocarcinoma of the prostate who have not received previous treatment (defined as prostatectomy, transurethral resection of the prostate [TURP], radiation of the pelvis, and GreenLight Laser Therapy) except for short-term (≤6 months) Androgen Deprivation Therapy (ADT) according to National Comprehensive Cancer Network (NCCN) guidelines.
- Candidate for definitive prostate radiotherapy (either IMRT or proton).
- Patients to be treated with IMRT should have all radiation treatment planned with IMRT, whereas patients to be treated with protons should have all radiation treatment planned with protons (including pelvic nodes if treated).
- Localized prostate cancer, as confirmed by staging with Prostate-Specific Antigen (PSA), biopsy, Gleason score, and clinical stage.
- Nuclear medicine bone imaging is required for confirmation of the absence of overt metastatic disease in bones if any high-risk criteria are identified (clinical stage T3a or higher; or 1-4 cores of Gleason score 8 [NCCN Grade Group 4] or 4+5; or PSA ≥20 ng/mL).
Key exclusion criteria (10 listed)
- Findings of metastatic disease (nodal or distant, >N1 or M1).
- Prior prostatectomy, TURP, radiation of the pelvis, or GreenLight Laser Therapy.
- History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
- The score for Question 16 (i.e., "Overall, how big a problem have your bowel habits been for you during the last 4 weeks?") of EPIC questionnaire is 3 or above.
- Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic) or documented history of inflammatory bowel disease requiring intervention.
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 |
|---|---|---|
| Collection of plasma samplesCollection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test. | Other | Evaluate toxicity biomarkers |
Primary outcome
To determine the cut-off values from the RadTox test results during early radiation treatment from all evaluable subjects to differentiate high toxicity score from average or low toxicity score.
Time frame: 1 year after radiotherapy
The cut-off values of all evaluable subjects will be measured based on the Receiver Operating Characteristic (ROC) analysis to optimize detection of true high-risk patients with ≥60% sensitivity and ≥60% specificity allowing for an acceptable number of high-risk classified but normal-risk patients.
1 secondary outcome
To determine the cut-off values from the RadTox test performed during early radiation treatment with patients categorized according to demographics and treatment options to differentiate high toxicity score from average or low toxicity score.
Time frame: 1 year after radiotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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.
Ann K Vallerga, PhD, MBA principal investigator
DiaCarta, Inc.
5 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 DiaCarta, Inc. at 5 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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the cut-off values from the RadTox test results during early radiation treatment from all evaluable subjects to differentiate high toxicity score from average or low toxicity score. (time frame: 1 year after radiotherapy). 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 28 Aug 2025.