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Radiation Therapy
CyberKnife Radiosurgery for Prostate Cancer
Phase 2
Waitlist Available
Led By Donald B Fuller, M.D.
Research Sponsored by CyberKnife Centers of San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition)
Karnofsky performance status >80
Must not have
Radical surgery for carcinoma of the prostate
History of inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will help determine if a new type of radiation treatment, called prostate radiosurgery, is more effective than other salvage treatments for locally recurrent prostate cancer.
Who is the study for?
Men with prostate cancer that has come back locally after previous radiotherapy can join this trial. They should have no distant spread of cancer, no lymph node involvement, and a life expectancy over 5 years. Participants need to be fairly active (Karnofsky score >80) and it must be more than 2 years since their last radiotherapy.
What is being tested?
The study is testing CyberKnife Radiosurgery, which targets radiation doses precisely at the tumor with fewer treatments but higher dose each time. It's compared against other salvage treatments like brachytherapy or surgery to see if it offers any benefits.
What are the potential side effects?
Potential side effects may include damage to surrounding tissues leading to gastrointestinal or urinary issues due to high-dose radiation in focused areas. The exact side effects will vary based on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has come back and is at an early to mid-stage.
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I can carry out normal activities without assistance.
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My cancer has not spread to my lymph nodes.
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My cancer has not spread to distant parts of my body.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had major surgery for prostate cancer.
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I have a history of inflammatory bowel disease.
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My cancer has spread to nearby lymph nodes.
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My cancer has spread to distant parts of my body.
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I have minor or no long-term stomach or urinary side effects from past radiation.
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My cancer is at stage T4 according to the AJCC 6th Edition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: CyberKnife RadiosurgeryExperimental Treatment1 Intervention
Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CyberKnife Radiosurgery
2007
N/A
~10
Find a Location
Who is running the clinical trial?
CyberKnife Centers of San DiegoLead Sponsor
1 Previous Clinical Trials
258 Total Patients Enrolled
1 Trials studying Prostate Cancer
258 Patients Enrolled for Prostate Cancer
Donald B Fuller, M.D.Principal InvestigatorCyberKnife Centers of San Diego
1 Previous Clinical Trials
258 Total Patients Enrolled
1 Trials studying Prostate Cancer
258 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had major surgery for prostate cancer.It has been less than 2 years since I finished my radiotherapy.I have a history of inflammatory bowel disease.It has been over 2 years since I completed my original radiotherapy.My cancer has spread to nearby lymph nodes.My prostate cancer has come back and is at an early to mid-stage.My cancer has spread to distant parts of my body.I have minor or no long-term stomach or urinary side effects from past radiation.My cancer is at stage T4 according to the AJCC 6th Edition.I can carry out normal activities without assistance.My cancer has not spread to my lymph nodes.My cancer has not spread to distant parts of my body.I have been cancer-free for over 5 years, except for certain skin cancers.
Research Study Groups:
This trial has the following groups:- Group 1: CyberKnife Radiosurgery
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.
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