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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
Must not have
No chemotherapy for a malignancy in the last 5 years
No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had chemotherapy for cancer in the last 5 years.
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I haven't had any cancer except for skin cancer in the last 5 years.
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I have not had prostate surgery or treatment, except for hormone therapy.
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I do not have inflammatory bowel disease.
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I have never had a pelvic or horseshoe kidney.
Select...
I have not had radiation treatment to my pelvic area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Document rate of biochemical Disease-Free Survival (bDFS)
Secondary study objectives
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Rate of disease-specific survival
Rate of distant failure
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
404 Previous Clinical Trials
884,870 Total Patients Enrolled
Ariel Hirsch, MDPrincipal InvestigatorBoston Medical Center

Media Library

CyberKnife Boost Clinical Trial Eligibility Overview. Trial Name: NCT01508390 — N/A
Prostate Cancer Research Study Groups: Boost
Prostate Cancer Clinical Trial 2023: CyberKnife Boost Highlights & Side Effects. Trial Name: NCT01508390 — N/A
CyberKnife Boost 2023 Treatment Timeline for Medical Study. Trial Name: NCT01508390 — N/A
~6 spots leftby Dec 2027
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