Hypofractionated Radiation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Xinglei Shen

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have had surgery to remove my prostate.

I have had radiation therapy to my pelvic area before.

Psychiatric illness/social situations that would limit compliance with study requirements

Participant Groups

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.

Group I: Hypofrac Radiation Therapy Experimental Treatment 1 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.

Hypofractionated Radiation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Hypofractionated Radiotherapy for:

• Endometrial cancer

🇪🇺 Approved in European Union as Hypofractionated Radiotherapy for:

• Endometrial cancer
• Cervical cancer

🇨🇦 Approved in Canada as Hypofractionated Radiotherapy for:

• Endometrial cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Kansas Medical Center/ Cancer Center Kansas City, KS

Who Is Running the Clinical Trial?

University of Kansas Medical Center Lead Sponsor

References