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Biomarker Analysis for Prostate Cancer Radiotherapy Toxicity Prediction (GARUDA Trial)

N/A
Waitlist Available
Led By Amar Kishan
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed, clinical localized adenocarcinoma of the prostate with no evidence of disease beyond the prostate and/or seminal vesicles
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

GARUDA Trial Summary

This trial is testing a way to predict which prostate cancer patients will experience long-term genitourinary toxicity after radiation therapy, so that patients and doctors can make more informed decisions about treatment.

Who is the study for?
Men with localized prostate adenocarcinoma, who have not had prior treatments like pelvic radiotherapy or prostate surgery, and do not have metastatic disease. They must be able to sign consent and follow the National Comprehensive Cancer Network guidelines for staging workups based on their risk group.Check my eligibility
What is being tested?
The trial is testing if knowledge of a patient's genetic predisposition to radiation toxicity (low or high risk) influences long-term genitourinary side effects after stereotactic radiation therapy for prostate cancer.See study design
What are the potential side effects?
Potential side effects include urinary issues such as increased frequency and discomfort, bowel changes, sexual dysfunction, fatigue, skin reactions in the treated area, and possibly other complications related to radiation.

GARUDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is confirmed and hasn't spread beyond the prostate or seminal vesicles.

GARUDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
5-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity
Secondary outcome measures
5-year biochemical recurrence-free survival
5-year cumulative incidence of Late grade >= 2 GU physician-scored toxicity
Change in patient-reported bowel quality of life
+6 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Nausea
64%
Dyspnea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anorexia
21%
Anxiety
21%
Fall
14%
Depression
14%
Wheezing
14%
Hypotension
14%
Diarrhea
14%
Dysphagia
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Dehydration
7%
Amnesia
7%
Dysuria
7%
Hearing impaired
7%
Hypertension
7%
Creatinine increased
7%
Dysgeusia
7%
Eye pain
7%
Confusion
7%
Dementia
7%
Hypernatremia
7%
Productive cough
7%
Hemorrhoids
7%
Pneumonitis
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Blurred vision
7%
Rash
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Sinusitis
7%
Alopecia
7%
Esophagitis
7%
Otitis externa
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

GARUDA Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiotherapy, genomic DNA testing)Experimental Treatment6 Interventions
Patients undergo SBRT per standard of care, then 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2021
N/A
~130
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
25,878 Total Patients Enrolled
MiraDXUNKNOWN
Amar KishanPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
5 Previous Clinical Trials
624 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624256 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are in the clinical trial at its peak capacity?

"Affirmative. Clinical trial records hosted on clinicaltrials.gov confirm that this medical research, which was first published on November 10th 2020, is still open for applicants. The study aims to enlist 200 participants from a single centre."

Answered by AI

Are there still vacancies available for participation in this experiment?

"According to the clinicaltrials.gov, this medical trial is currently recruiting participants with initiation of recruitment beginning in November 2020 and most recent update taking place on December 1st 2022."

Answered by AI
~105 spots leftby Dec 2027