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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

Must not have

Prior whole-gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate

History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed and hasn't spread beyond the prostate or seminal vesicles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cryosurgery, HIFU, or brachytherapy on my prostate.

Select...

I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.

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My prostate cancer is of the neuroendocrine or small cell type.

Select...

My cancer has spread to distant parts of my body.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

5-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity

Secondary study objectives

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

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Dysesthesia

13%

Dysgeusia

13%

Myalgia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Muscle weakness

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~180

Hypofractionated Radiation Therapy

2016

Completed Phase 3

~130