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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
Karnofsky performance status > 80
Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial shows that Virtual HDR CyberKnife is just as effective as the traditional method, but is less invasive and more comfortable for the patient.
Who is the study for?
Men over 18 with early-stage prostate cancer (T1b-T2b), a Gleason score of 7 or less, and PSA levels at or below 20 ng/ml can join. They must be in good health overall, able to perform daily activities without significant assistance (Karnofsky performance >80), and give informed consent. Men with advanced cancer stages, higher Gleason scores or PSA levels, lymph node involvement, distant metastases, recent hormonal therapy, major medical/psychiatric issues that could affect treatment adherence or follow-up are excluded.Check my eligibility
What is being tested?
The trial is testing CyberKnife Radiosurgery as a non-invasive alternative to traditional high dose rate brachytherapy for prostate cancer. It aims to treat the cancer effectively without hospital stays and catheters associated with conventional methods.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects from radiosurgery like CyberKnife may include urinary symptoms such as increased frequency and urgency; bowel changes; fatigue; skin reactions in the treated area; erectile dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out normal activities without assistance.
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My prostate cancer is in the early stages and hasn't spread to lymph nodes or other parts.
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I am 18 years old or older.
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My prostate cancer has a Gleason score of 7 or less.
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
To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CyberKnife RadiosurgeryExperimental Treatment1 Intervention
CyberKnife Radiosurgery
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
20 Total Patients Enrolled
Donald B Fuller, M.D.Principal InvestigatorCyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of inflammatory bowel disease.I have had major surgery or radiation for prostate cancer, or have metal in my pelvis.My cancer is not in the advanced stages according to a specific cancer staging system.My prostate cancer has a Gleason score above 7.I can carry out normal activities without assistance.I have been cancer-free for over 5 years, except for certain skin cancers.My prostate cancer is in the early stages and hasn't spread to lymph nodes or other parts.I am 18 years old or older.My prostate cancer has a Gleason score of 7 or less.My cancer has spread to nearby lymph nodes.I have not taken hormone therapy for my condition in the last 3 months.My cancer has spread to distant parts of my body.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a risky procedure or does it have a low chance of side effects?
"While there is some evidence for the safety of this treatment, it is only from a Phase 2 trial. This means that there is no data currently supporting its efficacy."
Answered by AI
Are we still looking for volunteers for this research?
"Unfortunately, this specific trial is no longer recruiting patients. The last update on clinicaltrials.gov was on July 18th, 2017. Although this study has completed recruitment, there are 1,367 other studies that are presently looking for participants."
Answered by AI
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