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Radiation Therapy
Hypofractionated Radiation for Prostate Cancer
N/A
Waitlist Available
Led By Xinglei Shen, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No other active malignancy
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 year post radiation
Awards & highlights
Study Summary
This trial is testing if a new way of treating prostate cancer, ultra-hypofractionation, is effective and has less urinary side effects.
Who is the study for?
Men over 18 with early-stage prostate cancer (T1-T2bN0M0, GS6-7, PSA < 20) who have a life expectancy of more than 10 years and are in good physical condition (ECOG score 0-1). They must not have had prior treatments like prostatectomy or pelvic radiation, no active other cancers or certain diseases like inflammatory bowel disease. Prostate size should be less than 50 cc.Check my eligibility
What is being tested?
The trial is testing ultra-hypofractionated radiation therapy to see if it increases urinary toxicity in men with prostate cancer. This involves giving higher doses of radiation in fewer sessions compared to traditional schedules.See study design
What are the potential side effects?
While the study focuses on urinary toxicity as a side effect, patients may also experience typical radiation-related effects such as skin irritation near the treatment area, fatigue, bowel changes like diarrhea or discomfort during urination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any other active cancer.
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I am 18 years old or older.
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My prostate is smaller than 50 cc.
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I am fully active or can carry out light work.
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I have early-stage prostate cancer with specific health indicators.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 year post radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 year post radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity Rates
Secondary outcome measures
Biochemical Control Rate
Financial Toxicity Measurement
Oxidative stress as a predictor of toxicity
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Hypofrac Radiation TherapyExperimental Treatment1 Intervention
All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.
Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan.
Each treatment should take about 10-20 minutes.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,144 Total Patients Enrolled
11 Trials studying Prostate Cancer
617 Patients Enrolled for Prostate Cancer
Xinglei Shen, MDPrincipal Investigator - University of Kansas Medical Center
University of Kansas Medical Center
2 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate symptoms score is low, under 15, or under 10 if I'm on medication like tamsulosin.I am allowed to receive hormone therapy for my condition.I am fully active or can carry out light work.I am 18 years old or older.I agree not to donate sperm during and for 3 months after the study.I have had surgery to remove my prostate.I do not have any other active cancer.I have had radiation therapy to my pelvic area before.I can sign a consent form.My prostate is smaller than 50 cc.I am being treated for inflammatory bowel disease or a connective tissue disease.I have early-stage prostate cancer with specific health indicators.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofrac Radiation Therapy
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 recruitment still underway for this experiment?
"Precisely. Clinicaltrials.gov documents that, as of September 1st 2020, this investigation is actively seeking enrolment from 30 participants at one medical centre - the study was originally published on March 22nd 2018."
Answered by AI
How many participants are being enrolled in this research endeavor?
"Indeed, based on the information provided online by clinicaltrials.gov, this study is currently seeking participants. It was posted on March 22nd 2018 and last edited September 1st 2020; with 30 volunteers being sought from a single location."
Answered by AI
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