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Radiation Therapy
CyberKnife SBRT for Prostate Cancer
N/A
Recruiting
Led By Arica Hirsch, MD
Research Sponsored by Advocate Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be ≥ 18 years of age.
No prior radiotherapy to the prostate or lower pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well Cyberknife SBRT works in treating patients with localized prostate cancer.
Who is the study for?
Men with intermediate or high-risk localized prostate cancer who haven't had radiotherapy to the prostate/pelvis, chemotherapy for other cancers in the last 5 years, or invasive malignancies (except certain skin cancers) in that time. They should have a good performance status, no prior prostate surgery like prostatectomy or cryotherapy, and appropriate organ function.Check my eligibility
What is being tested?
The trial is testing CyberKnife® SBRT as either standalone treatment for intermediate risk patients or as a boost before IMRT for both intermediate and high-risk patients. The goal is to see how well it prevents cancer from progressing over five years without causing serious side effects.See study design
What are the potential side effects?
Potential side effects include urinary issues such as increased frequency and urgency, bowel changes like diarrhea, fatigue during radiation therapy sessions, and possible sexual dysfunction due to radiation affecting nearby tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have not had radiation therapy to my prostate or lower pelvis.
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I haven't had any cancer other than this prostate cancer or skin cancer in the last 5 years.
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My prostate cancer has a Gleason score between 2 and 10.
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I have not had surgery or cryotherapy for prostate cancer.
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My breast cancer is at an early or locally advanced stage, but not spread to distant organs.
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My prostate cancer is classified as either intermediate or high risk based on its characteristics.
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My prostate is 100 cc or smaller.
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My prostate cancer was confirmed through a tissue examination.
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My cancer's size and spread to lymph nodes have been assessed.
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My cancer's spread was checked with a physical exam, CT, or MRI.
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I haven't had chemotherapy for cancer in the last 5 years.
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I am fully active or can carry out light work.
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
Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions
Secondary outcome measures
Measure Overall Survival
Measure clinical disease-free survival rates
Measure disease-specific survival rates
+3 moreOther outcome measures
Quality of life (QOL) in generic and organ-specific domains
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intermediate RiskExperimental Treatment3 Interventions
Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy
OR
Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
Group II: High RiskExperimental Treatment3 Interventions
Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyberKnife
2009
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Advocate Health CareLead Sponsor
53 Previous Clinical Trials
1,510,909 Total Patients Enrolled
Majid M Mohiuddin, MDStudy ChairAdvocate Lutheran General Hospital
Arica Hirsch, MDPrincipal Investigator - Advocate Lutheran General Hospital
Adventist Hinsdale Hospital, Advocate Condell Medical Center, Advocate Good Samaritan Hospital, Advocate Good Shepherd Hospital, Advocate Illinois Masonic Medical Center, Advocate Lutheran General Hospital, Alexian Brothers Medical Center, Central DuPage Hospital, Delnor Hospital, Emergency Healthcare Physicians Ltd, Kishwaukee Community Hospital, Northwestern Memorial Hospital, St. Alexius Medical Center
Northwestern University Medical Sch (Medical School)
Mem Sloan-Kettering Cancer Center (Residency)
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have not had radiation therapy to my prostate or lower pelvis.I haven't had any cancer other than this prostate cancer or skin cancer in the last 5 years.My prostate cancer has a Gleason score between 2 and 10.I have not had surgery or cryotherapy for prostate cancer.My breast cancer is at an early or locally advanced stage, but not spread to distant organs.My prostate cancer is classified as either intermediate or high risk based on its characteristics.My prostate is 100 cc or smaller.My prostate cancer was confirmed through a tissue examination.My cancer's size and spread to lymph nodes have been assessed.My cancer's spread was checked with a physical exam, CT, or MRI.I haven't had chemotherapy for cancer in the last 5 years.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Intermediate Risk
- Group 2: High Risk
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.
Is there a recruitment process in progress for this research project?
"Clinicaltrials.gov confirms that this medical trial, which was initially posted on November 19th 2013, is actively recruiting patients at the moment. The details of the study have been updated as recently as July 19th 2021."
Answered by AI
What is the highest number of participants this research trial can accept?
"Yes, the information on clinicaltrials.gov affirms that recruitment for this medical trial is ongoing. It was first made available to patients on November 19th 2013 and has since been revised on July 19th 2021. 72 individuals are required from a single site in order to complete the study's objectives."
Answered by AI
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