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Radiation Therapy
CyberKnife SBRT for Prostate Cancer (CK-DESPOT Trial)
N/A
Recruiting
Research Sponsored by Crozer-Keystone Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unfavorable Risk Prostate Carcinoma as Described is documented.
No prior Trans-urethral resection of the prostate (TURP).
Must not have
Contraindication to hormone therapy
Prostate size greater than 100cc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
This trial is testing whether CK-SBRT is an effective treatment for prostate cancer, especially in those with unfavorable types of the disease.
Who is the study for?
Men with a specific type of prostate cancer that hasn't spread, diagnosed within the last year. They should have a prostate size less than 100 cc, low urinary symptoms (AUA score <20), and no prior major prostate surgeries or pelvic radiation. Men who've had other cancers besides non-melanoma skin cancer in the past 5 years or those with implanted hardware near the prostate are not eligible.
What is being tested?
The trial is testing CyberKnife SBRT, an advanced form of targeted radiation therapy designed to increase dosage accuracy for treating unfavorable types of localized prostate cancer while minimizing damage to surrounding healthy tissue.
What are the potential side effects?
Potential side effects may include urinary issues, bowel discomfort, fatigue, sexual dysfunction, and skin reactions in the treated area. The precise nature and severity can 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 is classified as high-risk.
Select...
I have not had a TURP procedure.
Select...
My prostate is smaller than 100 cubic centimeters.
Select...
I have not had radiation therapy to my pelvic area.
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I haven't had any cancer besides non-melanoma skin cancer in the last 5 years.
Select...
My scans show no cancer spread to lymph nodes or distant parts of the body.
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I don't have any implants near my prostate that would interfere with treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take hormone therapy due to health reasons.
Select...
My prostate is larger than 100cc.
Select...
I have not had any cancer diagnosis except for non-melanoma skin cancer in the last 5 years.
Select...
My prostate cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0
Secondary study objectives
Biochemical Disease Free Survival
Disease Free Survival
Disease Specific Survival
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalated CyberKnife SBRTExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Crozer-Keystone Health SystemLead Sponsor
4 Previous Clinical Trials
194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is classified as high-risk.I have not had a TURP procedure.My prostate is smaller than 100 cubic centimeters.I cannot take hormone therapy due to health reasons.I have not had radiation therapy to my pelvic area.I haven't had any cancer besides non-melanoma skin cancer in the last 5 years.You have metal devices in your body that could interfere with the imaging tests.My prostate cancer was confirmed by a biopsy within the last year.My scans show no cancer spread to lymph nodes or distant parts of the body.My prostate is larger than 100cc.I have not had any cancer diagnosis except for non-melanoma skin cancer in the last 5 years.I am eligible for a procedure to insert a rectal spacer.My prostate cancer has spread to other parts of my body.I don't have any implants near my prostate that would interfere with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalated CyberKnife SBRT
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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