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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

Must not have

Prior prostatectomy

Prior pelvic radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 year post radiation

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to remove my prostate.

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I have had radiation therapy to my pelvic area before.

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I am being treated for inflammatory bowel disease or a connective tissue disease.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 year post radiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity Rates

Secondary study objectives

Biochemical Control Rate

Financial Toxicity Measurement

Oxidative stress as a predictor of toxicity

+2 more

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: 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.

0 / 8Eligibility criteria met