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SBRT Boost for Prostate Cancer
N/A
Waitlist Available
Led By Ariel Hirsch, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must belong to one of the following risk groups: PSA > 20 and < 150 and/or Gleason 8-10 and/or > clinical T3a and/or Clinical N1 OR PSA 10 - 20 AND Gleason 7 AND Clinical T2b - T2c
Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare two types of radiation therapy given to men with prostate cancer. One group will receive the CyberKnife boost in addition to standard treatment, and the other will not. The study will also look at how the different types of radiation therapy affect the quality of life for participants.
Who is the study for?
This trial is for men over 18 with prostate cancer, a Gleason score of 2-10, and no prior pelvic radiotherapy or prostate surgery. They must be able to have an MRI, not have inflammatory bowel disease or certain other health conditions, and agree to complete questionnaires.Check my eligibility
What is being tested?
The study tests if using CyberKnife for boost radiation therapy after standard treatments improves outcomes in prostate cancer patients. It compares this method against the usual Intensity Modulated Radiation Therapy boost while monitoring quality of life impacts.See study design
What are the potential side effects?
Potential side effects may include skin reactions 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...
My prostate cancer is classified as high risk based on PSA levels, Gleason score, or tumor stage.
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I am undergoing or planning to start hormone therapy and radiation for prostate cancer.
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My prostate is larger than 20cc but smaller than 100cc.
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I am fully active or can carry out light work.
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I am older than 18 years.
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My cancer has not spread to distant organs, except possibly lymph nodes.
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My prostate cancer was confirmed through a tissue examination.
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I've had specific scans for cancer in my abdomen, pelvis, and bones.
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My prostate cancer has a Gleason score between 2 and 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Document rate of biochemical Disease-Free Survival (bDFS)
Secondary outcome measures
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Rate of disease-specific survival
Rate of distant failure
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BoostExperimental Treatment1 Intervention
CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day
Find a Location
Who is running the clinical trial?
Boston Medical CenterLead Sponsor
384 Previous Clinical Trials
871,595 Total Patients Enrolled
Ariel Hirsch, MDPrincipal InvestigatorBoston Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is classified as high risk based on PSA levels, Gleason score, or tumor stage.I am undergoing or planning to start hormone therapy and radiation for prostate cancer.My prostate is larger than 20cc but smaller than 100cc.I am fully active or can carry out light work.I haven't had chemotherapy for cancer in the last 5 years.I haven't had any cancer except for skin cancer in the last 5 years.I have not had prostate surgery or treatment, except for hormone therapy.I do not have inflammatory bowel disease.I am older than 18 years.My cancer's stage is based on the AJCC 7th Edition.My cancer has not spread to distant organs, except possibly lymph nodes.I have agreed to fill out questionnaires.My cancer has not spread, except possibly to my lymph nodes.My prostate cancer was confirmed through a tissue examination.My cancer's T-stage was determined by a physical exam.I've had specific scans for cancer in my abdomen, pelvis, and bones.I have never had a pelvic or horseshoe kidney.I have not had radiation treatment to my pelvic area.My prostate cancer has a Gleason score between 2 and 10.
Research Study Groups:
This trial has the following groups:- Group 1: Boost
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are individuals currently being enrolled in this research project?
"Per the information on clinicaltrials.gov, this trial has ceased to accept new participants. Its first advertisement was posted in June of 2011 and it ended recruitment at the end of August 2022; however, there are 1,321 other trials actively recruiting right now."
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