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Radiation Therapy

SBRT vs IMRT for Prostate Cancer

Phase 3
Waitlist Available
Led By Rodney Ellis
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously untreated localized adenocarcinoma of the prostate with specific clinical findings
Prostate volume must be < 70 cc
Must not have
Prior radiotherapy that would overlap with study radiation therapy fields
Use of hormonal therapy is not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization to the date of death or last known follow-up date, assessed up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two types of radiation therapy to treat prostate cancer. Stereotactic body radiation therapy may work better than intensity-modulated radiation therapy.

Who is the study for?
Men with early-stage prostate cancer (stage IIA-B) who haven't had previous treatments are eligible. They must have a prostate size less than 70 cc, specific PSA levels depending on their Gleason score, and be in good physical condition. Men over 60 can have slightly more health issues. Only English, Spanish, and French speakers who agree to fill out questionnaires can join.
What is being tested?
The trial is comparing two types of radiation therapy for prostate cancer: Stereotactic Body Radiation Therapy (SBRT), which targets the tumor with high precision over a few days, and Intensity-Modulated Radiation Therapy (IMRT), which shapes radiation beams to the tumor's contours.
What are the potential side effects?
Potential side effects include skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort during urination, bowel changes such as diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prostate cancer that has not spread and hasn't been treated yet.
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My prostate is smaller than 70 cc.
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I was mostly active and able to carry out all my pre-disease activities up to 60 days before signing up.
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I speak English, Spanish, or French.
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My prostate cancer has a specific Gleason score and PSA level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiotherapy in areas that would be treated in this study.
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I am not using any hormonal therapy.
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My MRI shows I have stage T3 cancer.
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I have had cancer that spread within the last 2 years.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization to the date of death or last known follow-up date, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death or last known follow-up date, assessed 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
Disease Free Survival
Incidence of Patients-Reported Gastrointestinal and Genitourinary Toxicity
Secondary study objectives
Biochemical Failure
Distant Metastasis
Health Related Quality of Life
+6 more

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593
21%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body Radiation Therapy (SBRT)Experimental Treatment1 Intervention
Patients undergo Stereotactic Body Radiation Therapy (SBRT) at least every other day for 2-3 fractions per week for 5 fractions over less than 12 business days.
Group II: Intensity-Modulated Radiation Therapy (IMRT)Active Control1 Intervention
Patients undergo Intensity-Modulated Radiation Therapy (IMRT) once daily 5 fractions per week for 28 fractions over less than 32 business days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~950

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,076 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,239 Total Patients Enrolled
569 Trials studying Prostate Cancer
529,860 Patients Enrolled for Prostate Cancer
Rodney EllisPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials

Media Library

Intensity-Modulated Radiation Therapy (IMRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03367702 — Phase 3
Prostate Cancer Research Study Groups: Intensity-Modulated Radiation Therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT)
Prostate Cancer Clinical Trial 2023: Intensity-Modulated Radiation Therapy (IMRT) Highlights & Side Effects. Trial Name: NCT03367702 — Phase 3
Intensity-Modulated Radiation Therapy (IMRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03367702 — Phase 3
~215 spots leftby Dec 2027
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