Trials / Active Not Recruiting

Active Not RecruitingNCT04624256

Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy, GARUDA Trial

Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 208 (actual)

Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This trial studies the changes in long-term physician-scored genitourinary toxicity achieved in prostate cancer patients eligible for stereotactic radiation therapy when both patients and physicians have access to convincing but non-validated germline signature that can characterize patients as having a low or high risk of developing toxicity after radiation therapy. The information learned from this study may guide patients' and physicians' decisions on radiotherapy fractionation.

Detailed description

PRIMARY OBJECTIVE: I. To determine the impact on the 2-year cumulative incidence of late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, caused by presenting both the physicians and patients with the results of a non-prospectively validated biomarker panel that dichotomizes any given patient into having a high versus a low risk of late grade ≥2 GU physician-scored toxicity following stereotactic body radiotherapy (SBRT). SECONDARY OBJECTIVES: I. To determine the late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, in patients who test positive for the biomarker. II. To determine the late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, in patients who test negative for the biomarker. III. To observe the proportions of patients who choose to receive conventionally fractionated radiotherapy, moderately hypofractionated radiotherapy, and SBRT, based on being positive or negative for the biomarker thought to predict for late grade ≥2 GU toxicity. To determine the 2- and 5-year cumulative incidences of late grade ≥2 gastrointestinal (GI) physician-reported toxicity, as assessed by the CTCAE version 4.03 scale, following the same intervention as for the primary objective. IV. To determine the incidence of acute grade ≥2 GU and GI toxicity as assessed by the CTCAE version 4.03 scale, following the same intervention as for the primary objective. V. To quantify the temporal changes in patient-reported quality of life (QOL) outcomes, as assessed by the Expanded Prostate Cancer Index-26 (EPIC-26), International Prostate Symptom Scores (IPSS), and Sexual Health Inventory for Men (SHIM) QOL indices, following the same intervention as for the primary objective. VI. To determine the 5-year cumulative incidence of late grade ≥2 GU physician-reported toxicity, as assessed by the CTCAE version 4.03 scale. OUTLINE: Patients planning to undergo SBRT per standard of care undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care. After completion of radiotherapy treatment, patients are followed up at 1 ,3, 6, 9, 12, 18, and 24 months, and then every 6 months for 4 years.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Discussion	Patients and physicians engage in discussion
RADIATION	Hypofractionated Radiation Therapy	Undergo conventional hypofractionated radiation therapy
RADIATION	Hypofractionated Radiation Therapy	Undergo moderate hypofractionated radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

Start date: 2020-11-10
Primary completion: 2027-12-31
Completion: 2028-12-31
First posted: 2020-11-10
Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04624256. Inclusion in this directory is not an endorsement.