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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival
Incidence of Patients-Reported Gastrointestinal and Genitourinary Toxicity
Secondary outcome measures
Biochemical Failure
Distant Metastasis
Health Related Quality of Life
+6 moreSide effects data
From 2018 Phase 2 trial • 35 Patients • NCT0136059321%
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
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
~740
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,154 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,455 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Rodney EllisPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have prostate cancer that has not spread and hasn't been treated yet.I haven't had chemotherapy for my cancer in the last 3 years.I have not had radiotherapy in areas that would be treated in this study.I am not using any hormonal therapy.My prostate is smaller than 70 cc.I am under active surveillance for my condition and choose to be treated.I was mostly active and able to carry out all my pre-disease activities up to 60 days before signing up.My MRI shows I have stage T3 cancer.I have had cancer that spread within the last 2 years.I speak English, Spanish, or French.I had a physical and rectal exam within the last 60 days.I had a bone scan or sodium fluoride PET scan within the last 4 months.My prostate cancer has a specific Gleason score and PSA level.My cancer has spread to other parts of my body.My prostate symptoms are mild to moderate.
Research Study Groups:
This trial has the following groups:- Group 1: Intensity-Modulated Radiation Therapy (IMRT)
- Group 2: Stereotactic Body Radiation Therapy (SBRT)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Stereotactic Body Radiation Therapy (SBRT) have any long-term negative effects?
"Our team at Power has estimated the safety of Stereotactic Body Radiation Therapy (SBRT) to be a 3. This is because it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
What are the objectives of this research?
"The purpose of this 2-year clinical trial is to study Disease Free Survival. Additionally, the trial will also look at secondary outcomes like Distant Metastasis and Biochemical Failure. Finally, another outcome being evaluated is Health Related Quality of Life."
Answered by AI
In how many different medical facilities is this research project being conducted today?
"Currently, this clinical trial has enlisted 100 patients from across the United States including Texas Oncology-McKinney in McKinney, Regions Hospital in Saint Paul, Mercy Cancer Center - Elk Grove in Elk Grove."
Answered by AI
Is it possible to sign up for this experiment right now?
"This particular trial, which was last updated on 8/29/2022, is no longer actively recruiting patients according to the clinicaltrials.gov website. 786 other trials are currently looking for participants."
Answered by AI
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