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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 weeks3 visits

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

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

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

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

0 / 10Eligibility criteria met