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Radiation

Shorter vs Usual Radiation Therapy for Prostate Cancer

Phase 3
Recruiting
Led By Karen E Hoffman
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Summary

This trial is comparing two different types of radiation therapy for high-risk prostate cancer. One type, called stereotactic body radiation therapy (SBRT), involves giving higher doses of radiation over a shorter period

Who is the study for?
This trial is for men with high-risk prostate cancer confirmed by tests, a PSA level over 20 ng/mL, Gleason Score of 8-10, and certain conditions on imaging. Participants must have a prostate size under 100 cc without evidence of distant metastases. Men should be at least 18 years old with an ECOG Performance Status of 0-2 and no prior radiation in the same area.
What is being tested?
The study compares two types of radiation therapy: SBRT (five treatments over two weeks) versus usual radiation (20 to 45 treatments over four to nine weeks). It aims to see if the shorter SBRT prevents cancer return as effectively as the longer usual treatment.
What are the potential side effects?
Radiation therapy can cause side effects such as fatigue, skin reactions in treated areas, urinary issues like increased frequency or discomfort, bowel changes including diarrhea or pain, and potential sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate gland is smaller than 100 cc before starting hormone therapy.
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I can take care of myself and am up and about more than half of my waking hours.
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My prostate cancer diagnosis was confirmed through lab tests.
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My cancer has not spread beyond my pelvic nodes according to scans.
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My pelvic lymph nodes are enlarged, measuring at least 1.0 cm.
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My cancer is classified as cT3a-T3b, not cT4, based on exams or imaging.
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My prostate cancer is aggressive (Gleason Score 8-10).
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I haven't had radiation in the area where my current cancer is.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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
Metastasis-Free Survival (MFS)
Secondary study objectives
Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26)
Cost
Failure-Free Survival
+6 more
Other study objectives
Patient-reported outcomes

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Dyspnea
27%
Depression
27%
Platelet count decreased
27%
Anemia
27%
Pain
27%
Fall
27%
Lymphocyte count decreased
20%
Chills
20%
Edema limbs
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Chest pain
13%
Dysesthesia
13%
Edema
13%
Vomiting
13%
Tinnitus
13%
Skin infection
13%
Myalgia
13%
Rash
13%
Back pain
13%
Insomnia
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Weakness (limb)
13%
Weight loss
7%
Hypoxic respiratory failure
7%
Hypernatremia
7%
Seizures
7%
Headaches
7%
Death NOS
7%
Encephalopathy
7%
Gait disturbance
7%
Fever
7%
Sneezing
7%
Tremor
7%
Amnesia
7%
Oral lesions
7%
Neutrophil count decreased
7%
Photophobia
7%
Pleural effusion
7%
Proteinuria
7%
Urinary frequency
7%
Cognitive disturbance
7%
Muscle weakness
7%
Lung infection
7%
Acute kidney injury
7%
Hypertension
7%
Allergy (seasonal)
7%
Dysphagia
7%
Bruising
7%
Low white blood count
7%
Hypomagnesemia
7%
Nasal congestion
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anxiety
7%
Anorexia
7%
Creatinine increased
7%
Hypokalemia
7%
Erythema multitforme
7%
Headache
7%
Hearing impaired
7%
Hearing loss
7%
Lymphocytopenia
7%
Sleep apnea
7%
Urinary urgency
7%
Weakness (facial)
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (SBRT)Experimental Treatment1 Intervention
Patients undergo SBRT for a total of 5 treatments over 2 weeks.
Group II: Arm II (EBRT)Active Control1 Intervention
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,001,791 Total Patients Enrolled
567 Trials studying Prostate Cancer
529,809 Patients Enrolled for Prostate Cancer
NRG OncologyLead Sponsor
236 Previous Clinical Trials
101,066 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
Karen E HoffmanPrincipal InvestigatorNRG Oncology
~806 spots leftby Mar 2036
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