WITHDRAWN

Determination of Assay Cut-Off for the RadTox Test in Prostate Cancer Patients to Predict GI Radiation Toxicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-10-01

Study Completion:2023-09-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT04580667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 85 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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. * 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.	* 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.)

Inclusion Criteria

Exclusion 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 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.
* 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.

* 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.)

Contacts and Locations

Principal Investigator

Ann K Vallerga, PhD, MBA

PRINCIPAL_INVESTIGATOR

DiaCarta, Inc.

Study Locations (Sites)

University of Florida, Gainesville, FL

Gainesville, Florida, 32610

United States

UF Health Proton Therapy Institute

Jacksonville, Florida, 32206

United States

NY Cancer and Blood Specialists

New York, New York, 10028

United States

NY Cancer and Blood Specialists

Port Jefferson Station, New York, 11776

United States

NY Cancer and Blood Specialists

The Bronx, New York, 10469

United States

Collaborators and Investigators

Sponsor: DiaCarta, Inc.

Ann K Vallerga, PhD, MBA, PRINCIPAL_INVESTIGATOR, DiaCarta, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01

Study Completion Date2023-09-06

Study Record Updates

Study Start Date2020-10-01

Study Completion Date2023-09-06

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer