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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

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ClinicalTrials.gov Identifier: NCT04580667
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
DiaCarta, Inc.

Brief 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. 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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Collection of plasma samples

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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).
Other: Collection of plasma samples
Collection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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. [ Time Frame: 1 year after radiotherapy ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on the presence of prostate cancer.
Sampling Method:   Non-Probability Sample
Study Population
Male patients with undergoing radiation therapy for prostate cancer
Criteria

Inclusion Criteria:

  • 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 1-4 cores of Gleason score 8 [NCCN grade group 4] or 4+5; or PSA ≥20 ng/mL).
  • Subjects with NCCN very high-risk prostate cancer are eligible with negative prostate cancer specific PET/CT imaging (as long as they are metastasis free). This includes patients who have T3b-T4; or Primary Gleason pattern 5; or >4 cores with Gleason score 8-10 (NCCN grade group 4 or 5).
  • Diagnosed with NCCN low-risk; intermediate-risk; high-risk; or very high-risk disease that is characterized by only one of the following criteria: clinical stage T3A; or 1 to 4 cores of Gleason score 8 (NCCN grade group 4) or 4+5; or PSA ≥20 ng/mL.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580667


Contacts
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Contact: Ann K Vallerga, PhD, MBA 650-333-3152 annek@diacarta.com

Locations
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United States, Florida
University of Florida, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32610
Contact: Jessica Kirwan    352-265-8832    kirwaj@shands.ufl.edu   
Principal Investigator: Randal H Henderson, MD, MBA         
UF Health Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Robin Cacchio, RN, CCRP    904-588-1460    rcacchio@floridaproton.org   
Principal Investigator: Randal H Henderson, MD, MBA         
United States, New York
NY Cancer and Blood Specialists Recruiting
Bronx, New York, United States, 10469
Contact: Carmen Vicuna, CRC    718-732-4078    cvicuna@nycancer.com   
Principal Investigator: Richard Zuniga, MD         
NY Cancer and Blood Specialists Recruiting
New York, New York, United States, 10028
Contact: Carissa Pedersen, LPN    917-258-7633    cpedersen@nycancer.com   
Principal Investigator: Richard Zuniga, MD         
NY Cancer and Blood Specialists Recruiting
Port Jefferson Station, New York, United States, 11776
Contact: Joseph Battelli, BS, MS    631-675-5335    jbattelli@nycancer.com   
Principal Investigator: Richard Zuniga, MD         
Sponsors and Collaborators
DiaCarta, Inc.
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Responsible Party: DiaCarta, Inc.
ClinicalTrials.gov Identifier: NCT04580667    
Other Study ID Numbers: DIA.0009
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases